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FECAL TRANSPLANTS: A Guide

Framework for rational donor selection in fecal microbiota transplant clinical trials
Published: October 10, 2019

 
Am J Gastroenterol. 2020 Jan 10. doi: 10.14309/ajg.0000000000000499. [Epub ahead of print]
Understanding the Scope of Do-It-Yourself Fecal Microbiota Transplant.

Abstract

OBJECTIVES:
Fecal microbiota transplantation (FMT) has emerged as an effective treatment option for Clostridioides difficile infection (CDI) and is considered an investigational therapy for a number of other diseases. Social media has facilitated widespread exposure of the public to the gut microbiome and FMT, ultimately acting as a catalyst for the Do-It-Yourself (DIY)-FMT movement. The aims of this study were to identify factors that influenced willingness to pursue DIY-FMT including common indications, screening processes, sample preparation, and self-reported efficacy and safety outcomes.

METHODS:
A twenty-five-point cross-sectional survey was posted online through the websites and social media pages of the Peggy Lillis Foundation, The Fecal Transplant Foundation, and The Power of Poop. Responses were cataloged through the Research Electronic Data Capture tool, and descriptive analyses were performed.

RESULTS:
Eighty-four respondents completed the survey between January 2018 and February 2019. The majority were female (71%) and white (92%). Most (80%) reported performing FMT on themselves; 87% used Internet resources to assist in the process, and 92% knew their stool donor. Inflammatory bowel disease (35%) and irritable bowel syndrome (29%) were the 2 most common conditions that respondents attempted to treat. Only 12% reported adverse events, whereas 82% reported improvement in their condition.

DISCUSSION:
DIY-FMT is being used for many indications, including those for which there is little evidence. There was a high self-reported success rate among respondents with few adverse events. There is a need for increased awareness around DIY-FMT and research around this phenomenon, which may impact public health.


 
Drugs From Bugs: Why Gates, Zuck And Benioff Think The Next Blockbusters Will Come From Inside Your Gut
Forbes magazine Feb 7, 2020.


"The race is on for FDA approval of the first drug made from gut bacteria. But the science is young and unproven. At Oppenheimer in New York, Mark Breidenbach says investor enthusiasm in microbiome companies is on a downswing because “there is no consensus about what the microbiome can do.” Amusa is more bullish. “The science is turning,” he says. “When it comes through with proof, these biotech companies will be worth not hundreds of millions of dollars, but billions. " "


"In the U.S., more than a million people suffer from autism, and there are no drugs to treat it; an additional million have Parkinson’s. What would be the value of an FDA-approved drug for either condition? “I can’t give you a market size,” says Donabedian. “But if either one hits, it will be huge.”

Chris Howerton, a biotechnology analyst at Jefferies, a New York investment bank, is less shy. “If every single microbiome paper turns into a proven therapy, it could impact the drug markets for most major categories of disease, which together were worth $350 billion in 2018 in the U.S. alone,” he says. “The breadth of the microbiome’s potential application is really tantalizing.”



 
Two dead and four hospitalized after fecal transplants from OpenBiome:

It's concerning, but this organization has treated about 55,000 people according to the article, so it's still a good track record. No one should ever die though. At times only the sickest patients are getting these FMT treatments, people dying with C. difficile, so considering that, one could say it's still a very good safety record.
 
I think I made a breakthrough in my understanding of FMT and performing a DIY FMT a few months ago, just to let you all know!! Just not sure how or when I will communicate this. I haven't made another attempt at a DIY FMT yet.
 

Spooky1

Well-known member
Location
South Northants
Wow, sounds interesting.
I hear that Prof Brorody in Australia has claimed the Crohn's Cure, according to the Daily Mail. Yeah, just as i'm fighting cancer along comes a Crohn's cure, just my luck. Let's all be hopeful.
 
Wow, sounds interesting.
I hear that Prof Brorody in Australia has claimed the Crohn's Cure, according to the Daily Mail. Yeah, just as i'm fighting cancer along comes a Crohn's cure, just my luck. Let's all be hopeful.
Sorry to hear about the cancer my friend. I did read the latest paper Borody released about crohn's, it was nice to hear more people in very long remission without drugs and with FMT, and very likely cured.
 

Lady Organic

Moderator
Staff member
Profound remission in Crohn’s disease requiring no further treatment for 3–23 years: a case series
Gaurav Agrawal, Annabel Clancy, Roy Huynh & Thomas Borody
Gut Pathogens volume 12, Article number: 16 (2020)
 
Here are the results of a search of clinical trials posted/planned from 01/01/2018 to 06/16/2020 for fecal transplant in crohn's disease:
link to clinicaltrials.gov

There were 6 studies, 2 of them in the USA. This doesn't include any studies that are in progress before this date though. One study is using pills that they are making themselves, not the ones from openbiome found here link, which the cost is now about 4x what it was about a year ago from what I recall.
 
latest progress on a FMT pill by Vedanta biosciences which contains 16 strains of bacteria from clostridium cluster xiva and iv, intended to treat IBD. There is a phase 2 study planned for the next 12 months. link

This is not a full spectrum Fecal Transplant which would contain many more strains of bacteria from these groups of bacteria but could be enough to colonize the gut and begin to fix some of the damage to the microbiome which could be the main cause of chronic inflammation, dare I carefully say, a cure. But a Full spectrum fecal transplant could still be superior to these bacterial selections and include beneficial fungi and viruses too, as well as more strains, there are hundreds of strains, the human microbiome contains around 10,000 strains of bacteria and about 1000 species and some ibd patients not only have damage to clostridium but other groups of bacteria as well, although clostridium may be the most important group.
 
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Faecal microbial transplantation more effective and less costly than antibiotics to treat C-diff infections JUNE 29, 2020
by University of Birmingham


 
"We have used mice colonized with microbiotas from humans with inflammatory bowel disease to study what happens when these mice receive a microbiota transplant from a set of healthy humans. We find that the mouse gut immune system is changed by microbiota transplants, becoming broadly less inflammatory and protecting mice from colitis. "

 
A predictive index for health status using species-level gut microbiome profiling
"Herein, we introduce the Gut Microbiome Health Index (GMHI), a biologically-interpretable mathematical formula for predicting the likelihood of disease . GMHI is formulated upon 50 microbial species associated with healthy gut ecosystems. GMHI is the most robust and consistent predictor of disease presence (or absence) compared to α-diversity indices. Validation on 679 samples from 9 additional studies results in a balanced accuracy of 73.7% in distinguishing healthy from non-healthy groups."

"As researchers uncover more details regarding which gut commensals may play a significant role in host health and disease, a promising translational application of this knowledge would be towards developing analytical tests or quantitative methods that provide indication of one’s health based upon a gut microbiome snapshot "

 
82 year old man receives FMT for C diff and his alzheimers improves dramatically over the course of a few weeks, and cognitive tests return to normal after a few months.
 
Last edited:
Location
San Diego
I did a search on clinicaltrials.gov for studies on fecal transplant excluding completed and erroneous listings, and including studies that were currently active in some way, the results were 197 studies that were active as of today.

clinicaltrials.gov search
Impressive, but unfortunately only a small handful of them are looking at Crohn's. The vast majority are for C. diff and other infections, UC, IBS, and an assortment of random stuff. I think this reflects the realtive lack of success that FMT has shown in Crohn's feasibility studies up till now.
 
Impressive, but unfortunately only a small handful of them are looking at Crohn's. The vast majority are for C. diff and other infections, UC, IBS, and an assortment of random stuff. I think this reflects the realtive lack of success that FMT has shown in Crohn's feasibility studies up till now.

I took another look, and if you go through the search results there are 12 studies on FMT for crohn's, results # 25, 29, 44, 53, 63, 74, 91, 122, 131, 132, 157, 167. This doesn't include the completed studies though, but we don't need more studies we need better studies that improve on the method to increase efficacy rate.

I would list the links to the studies but I'm kind of busy right now!!
 
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IBD patients who had FMT for C. diff reported more improvements in there IBD then worsening. Microbiome diversity increased on average in all patients, and UC patient's microbiome resembled the donor microbiome more closely after FMT, then crohn's patients.

 
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Takeda-partnered Finch Therapeutics grabs $36M and looks to leapfrog the pack in microbiome R&D.
 
Danone North America Announces 2020-2021 Gut Microbiome, Yogurt and Probiotics Fellowship Grant
For the 9th year, $50,000 will be granted to graduate students exploring the critical role of the gut microbiome, yogurt and probiotics in human health.

 
Turning microbiome research into a force for health
A diverse group of researchers is working to turn new discoveries about the trillions of microbes in the body into treatments for a range of diseases.

Zach Winn | MIT News Office
Publication Date: January 5, 2021

“In almost every disease context that’s been investigated, we’ve found different types of microbial communities, divergent between healthy and sick patients,” says professor of biological engineering Eric Alm. “The promise [of these findings] is that some of those differences are going to be causal, and intervening to change the microbiome is going to help treat some of these diseases.”

 
10 patients with U.C. were given a single FMT to induce remission without drugs, with 10 patients in the control group to compare. Mayo score was decreased more in the FMT group at week 4 and 8 but not at 6 months. Microbiome diversity improved in fmt patients. Monotherapy with a single fresh FMT is an effective and safe strategy to induce long-term remission without drugs in patients with active UC.

My thoughts are there weren't much details about the methodology of FMT in this abstract, there was no improvement in the firmicutes which could the most important for IBD, but its always nice to have more evidence of FMT even though this wasn't much of an advancement on the procedure.
 
I think they should try and eradicate someone's micribiome first then reinstall a new one with fat. Just reset it all.
That might not be the best idea because many strains of bacteria that we have inherited from our mothers are very well suited for us. I have references for this but not on hand. might be better just to have a higher dose of donor microbiome and some FMT studies show fiber can help the new organisms take a permanent hold in the FMT patient.
 
I only say that because there was that one case of a cancer patient who had his immune system/microbiome wiped out by the cancer treatment which also fixed his crohns. Now, there is likely way more going on, but I thought it would be an interesting combo.
 
"In the study, the fecal transplants, which were obtained from patients with advanced melanoma who had responded to pembrolizumab, were analyzed to ensure that no infectious agents would be transmitted. After treatment with saline and other solutions, the fecal transplants were delivered to the colons of patients through colonoscopies, and each patient also received pembrolizumab.

After these treatments, 6 out of 15 patients who had not originally responded to pembrolizumab or nivolumab responded with either tumor reduction or long-term disease stabilization. "


 
$3M Grant Awarded to Orthopedics Researcher to Study the Role of the Gut Microbiome on Osteoarthritis
Michael Zuscik, PhD, says the research could lead to the first disease-modifying treatment for patients with osteoarthritis.
Author
Valerie Gleaton |
Publish Date
April 2, 2021


 
NEWS RELEASE 6-APR-2021
Gut microbiome plays role in autism
AMERICAN SOCIETY FOR MICROBIOLOGY
 
"The Microbiome Gains Momentum in Cancer Immunotherapy
Once an object of skepticism, microbiome-augmented cancer immunotherapy is being advanced by companies such as Synlogic, Vedanta Biosciences, and Persephone Biosciences

Vedanta Biosciences develops drugs made from defined bacterial consortia. One of these drugs, a cancer drug called VE800, addresses a challenge that may commonly occur with microbiome-engaging cancer immunotherapeutics. The problem is variability in microbiome signatures. Vedanta’s CEO, Bernat Olle, PhD, says that with cancer, there is no “night and day type of signature” like that seen with Clostridium difficile infections. Olle suggests that overcoming this problem will require big data sets, big sample sizes, and multiomic analyses.

By Julianna LeMieux, PhD May 3, 2021"

 
2,000-year-old human feces explain why we now suffer from more chronic diseases

From the study of these fecal samples, Aleksandar Kostic, Marsha Wibowo and their team reconstructed 498 microbial genomes, of which 181 show strong evidence of being ancient and of human intestinal origin. The researchers found that 61 of these genomes had not been described before.
Marsha wibowo explains that today’s gut microbiome is much less diverse than the old one. “Approximately 40% of the genomes that we recovered from the samples were previously undescribed species. This reduction is associated with chronic diseases such as obesity and metabolic syndrome ”. According to Wibowo, the causality between the lack of specific microbes and these diseases has been suggested by different studies in humans that show, for example, how “the transplantation of fecal microbiota from healthy donors to individuals with metabolic syndrome can improve the sensitivity to insulin”.


 
That was very Interesting that 2000 year old study.

Lots of people always say eat fruit veg eat greens.

But like that just said even fruit and veg are sprayed with chemical.

I don't think we will all be going back eating fresh organic diverse wild food.

Science will have to advance fix the food, actually I think when they fit a lot of gut health problems lifespan will increase and space travel will be starting.

Science will need to fix all of our chemical food, make it taste good but not with chemicals that will cause disease.

When they learn the right stuff to feed the gut this will come.

There is a lot of excitement to come, wish it would speed up.
 
FECAL TRANSPLANTS and how they could cure IBD.

While this guide discusses home-based fecal transplants, the opinion of Crohnsforum.com is that they should be done under the supervision of a trained clinician as fecal transplants are potentially dangerous. ALWAYS discuss any potential treatment with your doctor.
- Forum Admin



Fecal Microbiota Transplants(FMT) have induced sustained drug free remissions in both forms of Inflammatory Bowel Disease(IBD) and may have cured some cases of IBD in small trials, according to Gastroenterologist Doctor Thomas J. Borody MD, Ph.d. Details of these reports are listed in section 1.

There are 14 F.D.A clinical trials planned for the use of fecal transplant in both forms of IBD. In this post you will find out everything about them. Fecal transplants restore missing bacteria in IBD patients by obtaining them from healthy donors stool, mixing a stool sample with saline solution in a blender and giving it to the patient as an enema. This procedure has been performed successfully at home, but if your decide to do it, be sure to read the papers in the post below for expert instruction, don't just jump into it, donors need to be absolutely healthy. http://www.cghjournal.org/article/S1542-3565(10)00069-8/fulltext

Latest studies in IBD show reduced diversity of healthy bacteria that regulate the inflammatory response when compared to groups of healthy people without IBD. Therefore, it is believed by some scientists that the restoration of the bacteria in IBD patients will correct the abnormal inflammatory response. So far we have some good scientific evidence this may be the case, but it will take time to prove this theory with absolute certainty. With official reports of UC and Crohn's patients maintaining a drug free remissions for as long as 25 and 13 years, this provides some compelling supportive evidence that they may have been cured by FMT.

Other ways of performing a fecal transplant are orally through a nasogastric/duodenal/jujenal tube or pill form which is currently in development. So far the studies have shown when donors are well screened with blood tests and meet health criteria, this is generally a safe treatment.


My experiences with Fecal Transplants: In this thread i have posts which detail my experiances with FMT, I was trying to find a way to make a FMT pill which proved pretty difficult. I tried FMT 4x with 3 different donors, only one FMT led to improvements, such as gaining 10 pounds in 10 weeks, improved bowel movements, lowered anxiety, but the majority of my other symptoms remain so I will have to find a new donor and try it again, but I'm convinced doing this again will likely reduce the severity of my disease even more.

----Receive updates and notifications from this thread by subscribing via the upper right menu labeled THREAD TOOLS.----

Outline
1. History of Fecal Transplant in IBD: Its success so far
2. Clinical Studies Currently in progress
3. Testimonies.
4. General Information
5. How to select a Donor
6. How to perform a Fecal Transplant



------------------------------------

1. History of Fecal Transplants in IBD: Its Success So Far.


Dr. Borody Background

These studies were done by a doctor in Australia, Thomas J. Borody who is trained in Gastroenterology in addition to other education and experience in scientific research.

Educational/Career background on Doctor Borody.
BSc (MED) (HONS)(Bachelor of Science), MBBS (HONS)(Bachelor of medicine, Bachelor of Surgery), MD(Doctor of Medicine), PhD(Doctor of Philosophy), FRACP(Fellow of the Royal Australasian College of Physicians), FACG (Fellow of the American College of Gastroenterology), FACP (A Fellow in the American College of Physicians), AGAF (American Gastroenterology Association Fellow)

Link to his website where this information was derived-
http://www.cdd.com.au/pages/clinical_staff.html

Here is a link to the U.S. National Library of Medicine /National Institute of Health where a search on his name will show some of his published contributions to various Medical/Scientific journals, search results on this database reveal 74 references to his name which illustrate more documentation of his professional experience. These references date from as recent as 2013 to as far back 1979, spanning about 34 years.
http://www.ncbi.nlm.nih.gov/pubmed/?term=borody+t



Fecal Transplant Studies on IBD -

1989 – Doctor Borody first used fecal transplants in 55 patients with a wide range of Gastrointestinal disorders ranging from constipation, diarrhea of unknown cause, Crohn’s disease and ulcerative colitis. 20 were considered cured. 9 were improved and 26 were unchanged. At least one of the cured patients were cured of Crohn’s disease and one of ulcerative colitis. This is an early study so it was unknown how many times a transplant may have to be done to get any results.

http://www.cdd.com.au/pdf/publications/All Publications/1989-Bowel-flora alteration a potential cure for inflammatory bowel disease and irritable bowel syndrome, Med J Aust, vol 150, issue 10 p604.pdf


2003- Doctor T.J Borody tried this therapy on 6 patients with ulcerative colitis, that elimated all signs of disease symptoms without drugs ranging from 1-13 years after therapy. These patients are considered to be potentially cured since there is no sign of disease, no longer need medication beyond 2 years and they remain disease free to this day. This study was published in the journal of clinical gastroenterology.
http://prdupl02.ynet.co.il/ForumFiles_2/28701499.pdf

2011- The same researcher Dr borody reported results in a group of patients with Crohn’s disease and all patients obtained remission without drugs. These were severe cases that didn’t respond to any medication before doing the fecal transplant. The results and details of this study were presented at the American College of Gastroenterology’s (ACG) 76th Annual Scientific meeting in Washington, DC in November of 2011. Here is the Official news release from the American college of gastroenterology-
http://d2j7fjepcxuj0a.cloudfront.ne...2011acg_fecal-transplant-cdiff_FINAL_1025.pdf

references for the 2011 fecal transplant study on crohn’s
Some reports of the ACG meeting in 2011 on various news websites
http://www.medicalnewstoday.com/releases/236885.php
http://www.sciencedaily.com/releases/2011/10/111031114945.htm

2013
July- 14 year old boy with crohns achieves remission with FMT -http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3742951/?report=classic

September- Early results from the mcmaster study, news segment-
http://www.ctvnews.ca/health/experi...tionize-treatment-of-bowel-diseases-1.1445800

November - man with severe crohn's disease achieves complete remission without drugs and with only one fecal transplant delivered orally.
http://www.ncbi.nlm.nih.gov/pubmed/24222969?dopt=Abstract

November- patient with crohn's responds to fecal transplant
http://www.ncbi.nlm.nih.gov/pubmed/24239403
FULL TEXT
http://ecco-jcc.oxfordjournals.org/content/8/3/256



2014

March- Woman remains in remission for 13 years after recieving an oral fecal transplant for Crohns disease, she may have been cured. http://www.abc.net.au/news/2014-03-18/sydney-doctor-claims-poo-transplants-curing-diseases/5329836

additional source: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3868025/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3868025/figure/F2/

May-Mcmaster Ulcerative Colitis Study.
Mixed results, some bad responses while some very good responses to FMT.
http://www.medscape.com/viewarticle/824930

August - Beth Israel deaconess Medical center Crohn's Disease,
After 4 weeks of follow-up, 55% had clinical response; 36% were in clinical remission.
http://www.healio.com/gastroenterology/inflammatory-bowel-disease/news/online/{13d3a6cd-6dde-4871-b904-21770537217d}/fecal-microbiota-transplant-improved-symptoms-in-patients-with-crohns-disease

2015

January-Crohn's- 23 out of 30 patients achieve remission with one oral administration of Fecal Transplant.
http://www.ncbi.nlm.nih.gov/pubmed/25168749

March-Crohn's-
http://journals.lww.com/ibdjournal/...icrobial_Transplant_Effect_on_Clinical.7.aspx



Fecal Transplant History of use for C. Difficle Infection.

Here are some reports about the latest study on Fecal Transplants outperforming standard Antibiotic therapy for C. Diff.-
http://www.cbsnews.com/8301-204_162...cs-for-curing-diarrhea-caused-by-c-difficile/

Here is a link to the actual study published in the New England journal of medicine 2013
http://www.nejm.org/doi/full/10.1056/NEJMoa1205037#t=abstract

EXCERPT from the study-
“The study was stopped after an interim analysis. Of 16 patients in the infusion group, 13 (81%) had resolution of C. difficile–associated diarrhea after the first infusion. The 3 remaining patients received a second infusion with feces from a different donor, with resolution in 2 patients. Resolution of C. difficile infection occurred in 4 of 13 patients (31%) receiving vancomycin alone and in 3 of 13 patients (23%) receiving vancomycin with bowel lavage (P<0.001 for both comparisons with the infusion group). No significant differences in adverse events among the three study groups were observed except for mild diarrhea and abdominal cramping in the infusion group(fecal transplant) on the infusion day.







Here is a quote by University of Minnesota Doctor and Researcher Alex Khoruts
some info on him- http://www.med.umn.edu/gi/faculty/khoruts/

"Those of us who've been doing this procedure(fecal transplant) for some time didn't need any more convincing, but the large medical community needs to go through these steps," Dr. Alexander Khoruts, a gastroenterologist at the University of Minnesota in Minneapolis who was not involved in the new study, told Nature. "It's an unusual situation where we have more than 50 years of worldwide experience and more than 500 published cases, and only this far along does a randomized trial appear.”

link to quote- http://www.cbsnews.com/8301-204_162...cs-for-curing-diarrhea-caused-by-c-difficile/




2. CLINICAL STUDIES: Currently In Progress


These studies were found on www.clinicaltrials.gov. To verify their existence, enter the identifier code into the website search engine.

-----------------------------------------
Pediatric Inflammatory Bowel Disease(Ulcerative colitis)
Helen DeVos Childrens Hospital (HDVCH)
Grand Rapids, Michigan, United States, 49503
ClinicalTrials.gov Identifier: NCT01560819
Estimated Primary Completion Date: May 2013

recently released study results April 4, 2013-
http://www.sciencedaily.com/releases/2013/04/130405112859.htm

excerpt-
“Results showed that, 78 percent subjects achieved clinical response within one week while 67 percent subjects maintained clinical response at one month after FMT. Thirty-three percent subjects did not show any symptoms of ulcerative colitis after FMT. Patient's clinical disease activity (PUCAI score) significantly improved after FMT compared to the baseline. No serious adverse events were noted. “Patients often face a tough choice between various medications that have significant side effects. Allowing the disease to progress can lead to surgical removal of their colon," said Dr. Kunde. "Our study showed that fecal enemas were feasible and well-tolerated by children with ulcerative colitis. Adverse events were mild to moderate, acceptable, self-limited, and manageable by patients."


----------------------------------------------------------
Ulcerative Colitis
University of Washington
Seattle, Washington, United States, 98103
ClinicalTrials.gov Identifier: NCT01742754
Estimated Study completion Date: April 2013
------------------------------------------------------------------------
Ulcerative colitis
Academic Medical Center
Amsterdam, Netherlands, 1100DD
ClinicalTrials.gov Identifier: NCT01650038
Estimated study Completion Date: December 2013
------------------------------------------------------------------------
Ulcerative Colitis
Hamilton Health Sciences / McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
ClinicalTrials.gov Identifier: NCT01545908
Estimated Primary Completion Date: March 2014

-----------------------------------------------------------------------
Crohn's Disease
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
ClinicalTrials.gov Identifier: NCT01847170
Estimated Enrollment: 20
Study Start Date: May 2013
Estimated Study Completion Date: April 2014
-------------------------------------------------------------------------
Crohn’s disease and Ulcerative colitis
Seattle Children's Hospital
Seattle, Washington, United States, 98105
ClinicalTrials.gov Identifier: NCT01757964
Estimated Primary Completion Date: December 2014
--------------------------------------------------------------------------
Crohn’s Disease
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
ClinicalTrials.gov Identifier: NCT01793831
Estimated Study Completion date: December 2014
--------------------------------------------------------------------------
Ulcerative Colitis
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210011
ClinicalTrials.gov Identifier: NCT01790061
Estimated Study Completion Date: December 2014
--------------------------------------------------------------------------
Ulcerative Colitis
University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
ClinicalTrials.gov Identifier: NCT02058524
Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Primary Completion Date: June 2015
------------------------------------------------------------------
Ulcerative Colitis
University of South Wales
ClinicalTrials.gov Identifier: NCT01896635
Estimated Enrollment: 80
Study Start Date: September 2013
Estimated Study Completion Date: September 2016

-------------------------------------------------------------------------
Ulcerative Colitis
Texas Children's Hospital/Baylor college of medicine
ClinicalTrials.gov Identifier: NCT01947101
Estimated Enrollment: 10
Study Start Date: December 2013
Estimated Study Completion Date: December 2016

---------------------------------------------------------------------------

Crohn's Disease
Gastroenterology department, Saint Antoine Hospital
Paris, France, 75571
ClinicalTrials.gov Identifier: NCT02097797
Estimated Enrollment: 18
Study Start Date: March 2014
Estimated Study Completion Date: February 2016
------------------------------------------------------
IBD both forms
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University Nanjing, Jiangsu, China, 210002
ClinicalTrials.gov Identifier: NCT02016469
Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: February 2016

--------------------------------------------

--------------------------------
IBD both forms
Wolfson Medical Center, Holon, Israel.
ClinicalTrials.gov Identifier: NCT02033408
Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: January 2016

------------------------------------------------
Seattle Children's Hospital, David Suskind.
ClinicalTrials.gov Identifier:NCT02272868
Estimated Enrollment: 32
Study Start Date: October 2014
Estimated Study Completion Date: October 2016
3. TESTIMONIES.
-


Testimony #1

This is the best testimony I have found so far because it is so detailed. This is a guy who used his son and his wife as donors. You don’t have to watch the entire videos, you can skip to the parts I have defined in the summary to verify the story. You will notice in the last video that the energy in his voice changes and his speaking ability improves a bit and his mood seems slightly improved, which are signs his health has is improving due to the fecal transplants.


Video #1 –
video length- 33 minutes

Summary of video/skip to these parts-
2:52- 30 years old, Married for 8 years, Bachelors degree in Business Adminstration, Self Employed, Works in financial services industry, Healthy most of life. Has had ulcerative colitis for about 5 years.
7:20- Took antibiotics for 2 years for staph infections on legs, he suspects the antibiotics had something to do with his development of IBD as symptoms appeared while on antibiotics.
9:50 - Description of initial onset of disease.
14:30-19:00 Describes symptoms before doing the fecal transplant which include Fistula, fissures, hemmorhoids. Starting transplants on meds @ 40 mg prednisone recently at 80mg. explains all the medications he has tried during the course of his disease for IBD.
26:00 when and how he heard about fecal transplants


Video day#3-
Summary
1:25 bowel movement frequency reduced from 20X per day to around 2x per day, in about 5 days


Video Day #20
2:50 almost entirely off of medication at this point. he’s generally still doing very well bowel wise and feeling pretty good.
6:00 encourages people to try it, considers it a miracle for him and his condition.


Latest update April 30th, 2013-

0:00-3:30 gained 30 pounds since starting fecal transplants, eats a normal diet now and most symptoms are gone without medication.
3:30-7:32- tips on how to perform the transplant




Testimony #2-

His screen name is Dr. Briggs and he is a university physics professor who is trained as a scientist and who has done the treatment successfully at home using his wife as a donor.
link to the forum discussion where this testimony was found- http://www.healingwell.com/community/default.aspx?f=38&m=2541306&p=4

summary- he has had ulcerative colitis for 12 years, then later was diagnosed with crohn’s disease. He suspects that a course of antibiotics had something to with him developing IBD.
symptoms before starting the Fecal transplant were 3 bm’s per day, previously he has had up to 20 per day. after the transplants he averaged 2 bms a day and he was able to eat foods that used to cause his symptoms to worsen, this indicates a major change occurred in his ability to digest food.

A few quotes from his fecal transplant experience-
posted on 11/27/2012
Dr Briggs-
“So, things are going very well. To recap - I was diagnosed with UC about 12 years ago, and spent time on sulfasalazine and prednisone with no benefit (15-20 bloody very loose stools a day), then eventually Remicade after developing a fistula. I was on the Remicade for a little over 7 years, which partially controlled things (5-7 loose stools a day, no bleeding as long as I got infusions every ~11 weeks).
I am now off all medications, and doing great. Two well-formed stools a day.”

Posted 2/28/2013 1:14 PM

Dr briggs- “Sorry for not responding sooner (a lot sooner) - with my UC seeming to be completely gone, I'm getting caught up in other things, so I have to remind myself to occasionally check out this thread.
Potatoes are often not well digested if you have a compromised GI system, they have lots of complex starches in them. I can eat them now without problems, but before the transplants they gave me issues - and early on after the transplants when I ate potatoes they would give me a very mushy stool afterwards (I have continued healing since the transplants, and now tolerate everything very well it seems - except wheat). “




Testimony# 3

Here is another testimony from a women with the screenname bustersmom, she avoided a colectomy by doing a fecal transplant at home using her husband as a donor-
link-http://www.crohnsforum.com/showthread.php?t=15548&highlight=bacteriotherapy

post# 139
I have Crohn's disease and was on Flagyl and Cipro for over two weeks and got three abscesses. I figured i had nothing to lose by trying the transplant. I waited three weeks after finishing the antibiotics and was in bad shape. abscesses were terrible. I did the transplant daily for a while and the abscesses, Two which were large, Began to shrink every day. After a month they were gone, and made NO fistula! I haven't had one bit of trouble down there since. I believe the transplants work. I don't know if it works all through the colon, but it worked on me in my lower colon and i was a complete mess. Bree


Testimony#4

"Last Fall I went to Sydney Australia on a vacation and while I was there I looked into their programs and research. I found FMT. Fecal Microbiota Transplantation. I was grossed out and said oh hell no. Still, the more I studied and read the more it seemed worth a try. So, I called my doctor here and asked if I could be in one of the clinical studies. Unfortunately there wasn't one here. Only in Portland Oregon. He happened to know the doctor running the study though and offered me another way to treat myself at home. My husbands stool was tested for HIV, Hep A B and C, C Diff, and he passed all the tests with flying colors. So, we bought a retention nozzle, enema bag, tons of Zip lock freezer bags, went through training with our nurses so he could help me complete the series of enemas and my flora was checked and measured by my doctor every other week 7 days after each treatment. I was really sore down there from all the surgeries so instead of 7 days of back to back enemas we changed it to once every other week for 2 months.
I felt it was my last hope and I wanted to try something because nothing else seemed to work and I just wanted to become a guinea pig if I could. 4 months after my (home treatment) I went in for a scope, except some scarring from the past issues I had no inflammation, no diarrhea, no pain, and had started to work out again. I have felt better this past year than I have since I was 26. I have my life back! I have not been on any meds for 6 mos and after my scope today I was told I was in complete remission. (They still don't know how long it may last or if it will.) Right now I feel normal, no pain, no D and I have energy again!"

source-
http://www.crohnsforum.com/showthread.php?t=48939

4. GENERAL INFO
Here are some general videos explaining how this treatment has potential for IBD and many other diseases. Various environmental toxins and even antibiotics are suspected to be involved in damaging intestinal bacteria, which may contribute to developing these conditions.



Video Interview of Professor Lawrence J. Brandt.
Here are some credentials/education: Chief Emeritus of Gastroenterology and Professor of Medicine and Surgery at the Albert Einstein College of Medicine. He also has been performing studies on fecal transplants in C difficile in the U.S. since about 1999. C difficile is very similar to Inflammatory Bowel disease which the mains symptoms are chronic diarrhea and often include colonic inflammation just like inflammatory bowel disease.

Link to verify Professor Brandt’s credentials http://www.einstein.yu.edu/departme...gy-liver-diseases/faculty/profile.asp?id=2519



Part 1-
-talks about his experience studying fecal transplants for C. Difficile Infection.

Part 2- http://www.youtube.com/watch?v=ot7e9bQO2U8
-his opinion on fecal transplant overall safety, and its potential for other diseases.

Part 3- http://www.youtube.com/watch?NR=1&feature=endscreen&v=u8eNvAVfc0M
SUMMARY-
1:10 history of fecal transplant in veterinary medicine
2:18 different routes of administration of Fecal transplant
3:00 self/home administration of fecal transplant
4:00 more on the future and potential of Fecal Transplant
5:38 mentions pill form as the final future method of administration in the future for fecal transplant.


here is an article published on February 13, 2013 by Lawrence J. Brandt and another professional which was published in current opinion in gastroenterolology

Fecal Microbiota Transplantation: Past, Present and Future
Olga C. Aroniadis, Lawrence J. Brandt
Curr Opin Gastroenterol. 2013;29(1):79-84.
link to article-
http://www.medscape.com/viewarticle/776501_1


Video, By Cara Louise Santa Maria - Science educator, Masters
Degree in Neuroscience
link- http://www.youtube.com/watch?feature=endscreen&NR=1&v=kLB5Pasjjis



Here is a very well written article On FMT by KSS , a member of this website. there are testimonies of people who have tried Fecal transplant in this article.
http://diyehr.com/analysis-of-crohn...e-peer-to-peer-observational-treatment-study/


Article for TIME magazine in June 2012 about microbiome research-
http://healthland.time.com/2012/06/14/the-good-bugs-how-the-germs-in-your-body-keep-you-healthy/


http://commonfund.nih.gov/hmp/overview


Dr. Martin Blaser has studied the role of bacteria in human disease for over 30 years. He is the director of the Human Microbiome Program at NYU. His new book was just published and discusses the new evidence suggesting antibiotics have contributing to rising rates of diseases like Crohn's by killing off good microbes. - http://martinblaser.com/

http://www.npr.org/2014/04/14/302899093/modern-medicine-may-not-be-doing-your-microbiome-any-favors

http://www.amazon.com/gp/product/08...iveASIN=0805098100&linkCode=as2&tag=yoadsu-20

--------------------------------------------

5. How to Select a Donor

Overall, as long as the Donor is in good health, there is very little risk with doing a fecal transplant. Even in some of the documents below they reported bypassing blood tests and health screening for some patients who chose a donor that was a family member that they knew and trusted, buts it probably best to take precautions. All the criteria for selecting a healthy donor and directions for what blood tests they need were obtained from these two papers, one of which was written by doctor Borody and other professionals in the field.



Requirements:
NO ANTIBIOTICS IN LAST 6 MONTHS, OR EVER IS BEST.

NO Gastrointestinal COMPLAINTS LIKE FREQUENT DIARHEA OR CONSTIPATION/excessively firm stool that is hard to pass, blood, No Mucus in stool or intestinal pain. You should have a generally regular stool frequency of 1-2 bowel movements per day.


Absence of metabolic syndrome- http://en.wikipedia.org/wiki/Metabolic_syndrome
Symptoms and features are:
-Fasting hyperglycemia — diabetes mellitus type 2 or impaired fasting glucose, impaired glucose tolerance, or insulin resistance
-High blood pressure
-Central obesity (also known as visceral, male-pattern or apple-shaped adiposity), overweight with fat deposits mainly around the waist
-Decreased HDL cholesterol
-Elevated triglycerides
Associated diseases and signs are: hyperuricemia, fatty liver (especially in concurrent obesity) progressing to NAFLD, polycystic ovarian syndrome (in women), and acanthosis nigricans.

No autoimmune conditions- list of conditions-
link- http://womenshealth.gov/publications/our-publications/fact-sheet/autoimmune-diseases.cfm#d

No allergic diseases - asthma, atopic dermatitis (eczema), allergic rhinitis (hay fever), food allergies



Required Blood Tests for donors- full blood count, liver function,
Negative viral screening for HIV 1 and 2, Hepatitis a, b, c. cytomegalovirus, Epstein Barr Virus, Syphilis.



Some studies have bypassed donor screening only in cases where close family members have been selected as donors.

None of the Testimonys I listed in sections #4 of this paper mentioned taking the suggested precautions to follow the donor selection criteria, as most were able to get help from family members who they were confident were healthy. I plan on taking full precautions no matter how healthy my donor is, or whether they are a family member or not. I also have additional criteria that go beyond the advice listed here.

The papers below is where i found most of this information. It is not required that you read these papers with the web links listed below, but if you would like to look them up to verify they exist, feel free to do that.

Article 1
Details on page 3-
http://www.2ndchance.info/inflambowel-Hamilton2011.pdf

Article 2
Details on page 479-
http://www.cdd.com.au/pdf/publications/paper12.pdf




Recommended diet for donors- this will encourage all the good bacteria in your intestine to grow and make it a more potent medicine.
High fiber foods, like whole grain oats and wheat
Berries.
eat at least one apple per day.
veggies.
if you smoke, reduce your smoking as much as possible.

Things to avoid- anything with aspartame or saccharin in it, excessive meat. excessive amounts of processed food in packaging as it may contain preservatives that inhibit bacterial growth.
over consumption of meat- beyond 8 ounces in a day would be excessive.

other tips-
if you become sick or get food poisoning while doing the transplants you will have to stop until you become better.

--------------------------
6. How To perform a Fecal Transplant

chapter a work in progress


RECTAL METHOD/BY ENEMA
I have not included yet any details on how the transplant is done in any precise way, but typically it is done by making a solution of saline (.9% sodium chloride solution/aka salt water) mixed with stool in a blender and giving it as an enema to retain in the body for 6-8 hours or as long as your body can hold it. I will add more very soon but i think it's all here if you want to figure out the details for yourself, otherwise i will soon give some better instructions to make it easy for people to try themselves. There are some details on page 5 and 6 of this paper by doctor borody.
http://www.cdd.com.au/pdf/publications/paper12.pdf

how to make saline solution at home-Quick instructions- mix one gallon of distilled water with 4 teaspoons of salt(preferablly pharma grade neti pot salt) in a pot and stir on low heat so salt easily dissolves. this will make a gallon of saline solution.

.9% sodium chloride w/v solution is expressed as a mass concentration weight/volume solution. in other words, it is telling us how much mass of a certain substance is dissolved within a volume of a fluid. in this case, 100 milliliters of a fluid. and in this case sodium chloride aka salt. So there is .9 grams(just shy of one full gram) of salt dissolved in every 100 milliliters of h20 aka water.

more to come...
I can say this if my test comes back crohns, PLEASE PUT ME INTO THIS TEST PROGRAM or let me know how i ask a doc about this?
 
A Microbiome Therapeutic May Contain the One or the Many
Two companies—Federation Bio and 4D pharma—pursue very different strategies when they deploy their disease-fighting bacterial strains

By Julianna LeMieux, PhD

June 30, 2021


The more, the merrier
Federation Bio takes a “go big or go home” approach to microbiome drug development by building extraordinarily large and diverse communities of bacteria. Why does Federation Bio plan to pack many bacterial strains into its drugs, while other companies use a small group of bacteria or even just one?

It’s a “philosophical difference,” Conley declares. Bacteria live in a dense ecosystem with other bacteria. Based on that, Federation Bio believes that using bacteria to establish the ecosystem, in addition to the drug of action, will allow the bacteria to durably engraft and perform their functions more efficiently. This, Conley says, would be more challenging with a single strain. In her view, it is possible to find a single, magic strain, but putting such a strain into an imbalanced microbiome—an environment that is in a state of dysbiosis—would be “like putting a fish into a tree and expecting it to thrive.”
 
Vedanta Biosciences Completes $68 Million Series D Financing
Jul 21, 2021
Proceeds expected to be used primarily to support a Phase 3 trial of lead candidate VE303 in Clostridioides difficile infection (CDI) and a Phase 2 trial of VE202 in inflammatory bowel disease (IBD)
Topline data from Phase 2 trial of VE303 in CDI are anticipated in Q3 2021
Plans to initiate Phase 2 trial of VE202 for treatment of mild to moderate ulcerative colitis in H2 2021
 
This isn't good news for their product to treat Ulcerative Colitis, but its nice to know what is happening.


Seres Therapeutics’ microbiome therapy flops against placebo as shares go into freefall
by Ben Adams|
Jul 22, 2021 7:30am


"Shares in the microbiome biotech fell more than 52% to $9.90 in early, premarket trading Thursday morning, from a prior close of $20.73. The fall was precipitated by data from a phase 2 trial which saw the company's ulcerative colitis (UC) candidate SER-287 flop against placebo in improving clinical remission rates, its primary endpoint.

“Given the lack of a clinical efficacy signal identified in ECO-RESET, the company has decided to close the open label and maintenance portions of the study,” the biotech said in a statement.

The company will, however, push on with a similar bacteria-derived therapy in its SER-301 program, which is currently in a phase 1b study aiming to reduce intestinal inflammation and improve epithelial barrier integrity in adults with mild-to-moderate UC. Questions will however be asked over how much faith can be put in its whole business plan, given how much of its pipeline rests on a similar approach."

 
My thoughts: Well scientists have been saying that c diff is a natural resident of the human microbiome, and what makes it virulent is damage to other bacteria that keep its populations from growing out of proportion, so this finding seems to agree with that understanding. Antibiotics being the #1 cause of c diff as far as i recall, due to their ability to disturb the microbiome, in a similar way to how antibiotics might cause IBD too.

C Diff  Eradication Not Necessary for Clinical Cure of Recurrent Infections With Fecal Transplant
Tara Haelle

July 26, 2021

It's not necessary to completely eradicate all Clostridioides difficile to successfully treat recurrent C difficile infections with fecal microbiota transplant (FMT), according to a study presented online July 12 at the European Congress of Clinical Microbiology & Infectious Diseases.
C difficile colonization persisted for 3 weeks after FMT in about one quarter of patients, but it's not clear whether this is a persistent infection, a newly acquired infection, or partial persistence of a mixed infection, said Elisabeth Terveer, MD, a medical microbiologist at Leiden University Medical Center, Leiden, the Netherlands. Additionally, "82% of patients with detectable C diff do not relapse, so it's absolutely not necessary for a cure," she said.

 
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