Pig parasite as Crohn's treatment

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basically I collected a lot of information regarding TSO!

But I think you can find all information in internet! But I will provide the most interesting, becouse I was involved in clinical study with TSO.

rom: Aditya Reddy [[email protected]] Bernard Fried [email protected]

Dear Igor,

The Trichuris suis egg cocktail procedure is still experimental
(investigative) in the USA and is not FDA approved. There are some risks in egg preparation and delivery of the egg cocktail per os including the possibility of introducing unknown pathogens associated with the eggs (microbial pathogens). It is difficult to prepare the egg cocktail without assurance that it is pathogen free since bacteria, viruses, small protozoa and even rickettsial organisms have been associated in or on helminth eggs. For this reason and others the egg cocktail procedure has not been approved for use in the USA. It has been used in Mexico and in Europe and could possibly be obtained via mail order.

In Europe the company OVAMED has prepared the Ts egg cocktail for use in humans. Dr Frieds colleague at the USDA (Joseph F. Urban) has been involved in developing the cocktail from Ts raised in pigs in the USDA facility in Beltsville (strictly for investigative purposes) and supplied some of the original egg material for the Iowa trials (work of Weinstock, Summers and others). Some of the work of the early experimentalists on this topic (and references) can be found in the recent review by Reddy and Fried (which you have just alluded to) on this topic and of course our earlier review on this topic (also in Parasitol Res). I think for now at least you should stay with the more traditional treatments for Crohn's and related autoimmune diseases until further work on helminth therapy as an alternative mode of teatment is done and hopefully considered for approval by the FDA.

Best wishes,
Drs. Aditya Reddy and Bernard Fried
…………………………………………………………………………………………………………………………………… ………………………………….
From: Weinstock, Joel [[email protected]]
Dear Igor,

Thank you for writing. I am sorry to hear that you have CD. The agent that we developed is called T. suis or TSO. It is working its way through both the US and European food and drug administrations. To learn more, you may wish to visit the web site of Ovamed, which is one of the pharmaceutical companies producing the agent for the various clinical trials. I have no connection with hookworm or hookworm studies. I wish you and your family all the best.

Best wishes,

Joel Weinstock
…………………………………………………………………………………………………………………………………… …………………………………
From: Kubinec, Heather [[email protected]]
Dear Igor,

We provide funds for research grants into Crohn's disease and ulcerative colitis. We do not perform clinical research studies.

I do not know of any current trials for hookworms and Crohn's disease. However, I would recommend you periodically check http://clinicaltrials.gov/ , which lists current government and private clinical trials worldwide and is searchable.

Best wishes,

Heather Kubinec
Senior Research Administrator

the
broad foundation
scientific | medical research

10900 Wilshire Boulevard | Twelfth Floor Los Angeles, California 90024
310.954.5091 phone
310.954.5092 fax
[email protected]
www.broadmedical.org
 
Could you please inform me about new or ongoing clinical researches in field parasites treatment for Crohn's disease?)
ответа я не получаю...


Статья - http://www.hindawi.com/journals/jbb/2010/743758.html

Yoshio Osada [[email protected]]
Письмо:
Dear Mr. Igor ХХХХХ,

Thank you for your interest in my paper.
Unfortunately, I myself am not working on any clinical trials of helminth-based therapy. I am only working on basic experimental studies using laboratory animals. I advise you to contact with other clinical research groups directly.

I feel sorry for not being able to help you.

Best regards,

Yoshio Osada
 
From: [email protected]

Dear Igor,
Thank you for the inquiry. We are a small clinic that operates out of Mexico. We provide various endo and ecto parasites for the purpose of modulating the immune system.
Clinical trials with hookworm are currently recruiting in Nottingham, U.K.
We do not have any immediate plans to expand to CIS countries.
Sincerely,
Garin Aglietti
www.wormtherapy.com
888-898-WORM
Wormtherapy makes no claim to medical authority and nothing in this document
should be interpreted as medical advice. Wormtherapy is an experimental therapy
that has not been approved by any governmental body, including the FDA, for the
diagnosis, prevention or cure of any disease/condition.
 
Information from FDA:

Dear Mr. ХХХХ:

As a follow-up to my last e-mail, I would like to clarify the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) does regulate the use of hookworms for treatment; however, there are currently no approved treatments that use hookworms for the treatment of Crohn’s Disease. As such, FDA is prohibited by the Code of Federal Regulations from disclosing, or even acknowledging any information regarding unapproved products unless the information has already been publicly disclosed by the sponsor or the sponsor has provided written consent for FDA to release such information.

I hope this helps.

Sincerely,

JB

Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
US Food and Drug Administration

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.


Dear Mr. XXXX:

Thank you for your recent inquiry to the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) regarding the use of hookworms for the treatment of Crohn’s Disease. CBER, one of seven centers within FDA, is responsible for the regulation of biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines and allergenic extracts, and cell, tissue and gene therapy products.

Unfortunately, we will be unable to provide you with the information you are seeking. Federal regulations (21 CFR 601.50 and 21 CFR 601.51) prohibit FDA from disclosing, or even acknowledging any information regarding unapproved products unless the information has already been publicly disclosed by the sponsor or the sponsor has provided written consent for FDA to release such information. You may want to query medical search engines such as PubMed (http://www.ncbi.nlm.nih.gov/pubmed/) or Medline Plus (http://medlineplus.gov/) to learn more about current medical research into the use of hookworms for the specific use you seek.

Additionally, you may visit http://www.clinicaltrials.gov to see if there are any clinical trials related to the use of hookworms for the treatment of Crohn’s Disease. This website provides regularly updated information about federally and privately supported clinical research in human volunteers conducted in the United States and around the world. It will provide you with the information on the product being investigated, the trial’s purpose, who may participate, status of trial, sponsor, locations, and phone numbers for more details. You may also want to contact one or more of the sponsors directly for additional information.

We hope this information is helpful.

Sincerely,

JB

Consumer Affairs Branch
Division of Communication and Consumer Affairs
Center for Biologics Evaluation and Research
US Food and Drug Administration

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
 
I spend a lot time for this! More that year!
And at the end

Dear Mr. XXXX,

Thank you for your request with respect to Trichuris suis ova (TSO).

First American studies by patients with Morbus Crohn and ulcerative colitis showed, that therapy with TSO has a positive effect on the process of inflammatory bowel diseases (IBD), see attached Summers (2005).
From that time Dr. Falk Pharma is working on developing an adequate pharmaceutical.
Now the American studies should be confirmed with a multicenter study by Morbus Crohn.The study has started not yet, it is depending on the approval from the authorities.
Sorry, but for the first clinical trial by Dr. Falk Pharma and TSO the Ukraine is not involved.

We wish you all the best for your heatlh .

Kind regards,


Dr. Renate Grieshaber
Medizinische Wissenschaft/Medical Science Dr. Falk Pharma GmbH
Registergericht: Amtsgericht Freiburg, HRB 3266;
Geschäftsführerin: Ursula Falk
Leinenweberstr. 5
79041 Freiburg (Germany)
Tel.: ++49 (0) 761/ 15 14 299
Fax. ++49 (0) 761/ 15 14 377
e-mail: [email protected]
 
next one in German! I understand German so you can use google translator

Sehr geehrter Herr XXXX,

Wann und wo klinische Studien mit TSO stattfinden ist noch nicht genau
festgelegt.
Klinische Studien, d.h. Studien mit Menschen können erst beginnen, wenn die
Genehmigung des Amtes vorliegt (Termin derzeit unbekannt).
Studien in den USA sind nicht verboten.
Das TSO-Patent stammt von der Universität in Iowa und wurde u.a. an Dr.
Falk Pharma verkauft.

Mit freundlichen Grüßen

Dr. Renate Grieshaber
Medizinische Wissenschaft/Medical Science
Dr. Falk Pharma GmbH
Registergericht: Amtsgericht Freiburg, HRB 3266;
Geschäftsführerin: Ursula Falk
Leinenweberstr. 5
79041 Freiburg (Germany)
Tel.: ++49 (0) 761/ 15 14 299
Fax. ++49 (0) 761/ 15 14 377
e-mail: [email protected]
 
Last edited:
and I received information from OVAMED (producer of TSO)

Dear Mr ХХХХХ,
Thank you very much for your interest in our product TSO (/Trichuris suis/ ova). According to your E-Mail, I am very glad to send you the requested information and also a form if you would like to order.
Until we receive the manufacturing permission, you can receive TSO as a biological organism. For that we will need a note or prescription from your doctor that supports a therapy of TSO and that it will be accompanied by her/him. Enclosed you can find a fax order, by interest, which you can send to us with the doctors prescription via fax, mail or e-mail
A TSO therapy includes 10 doses/ bottles (every two weeks 1 dose).
TSO is available in three different types of doses.
* 500 eggs per unit / 150,00 € per unit
* 1000 eggs per unit / 220,00 € per unit
* 2500 eggs per unit / 300,00€ per unit
All Prices are net prices, therefore there will be an additional 19% taxes plus 60€ for he shipment. A therapy with TSO will last for about 20 weeks (=10 bottles per therapy). Every 2 weeks there should be ingested one bottle. You can mix the liquid of TSO with any juice since the taste is very salty. Please avoid mixing it with hot beverages or alcohol. In order to make sure that all TSO come to activity, also the ones at the edges, the bottle should be refilled with water and be taken a second time.
The choice of the dosage stands in relation to the heaviness of inflammation. By adult patients with MS, Crohn or Colitis we recommend a dose with 10 x TSO2500. Allergy patients can start with 3 x TSO1000 and further 7 x TSO2500. The storage has to be in the refrigerator by a temperature between 4° C to 8° C degrees (DO NOT FREEZE!!!) The Trichuris Suis Ova has no side effects. Do not compare it with the hookworm. The Hookworm is the parasite which can alive in human beeing and go through the blood stream into the lung, brain and and other organic. The Pigworm (TSO) can just alive in pigs. They will be degest within 24 hours. You do not need to visit a German Clinic!
By further questions please do not hesitate to contact me. I am looking forward to hear from you.
Kind regards,
Morsal Haidari
--
Ms. Morsal Haidari Kundenbetreuung/Customer Relations
Ovamed GmbH Kiebitzhörn 31 22885 Barsbüttel
Webpage: www.ovamed.org Email: [email protected]
Tel. +49 (0)40-675095-0 Fax: +49 (0)40-675095-59



Dear Igor,

you just need a doctor's prescription. Attached you will find a sample, which your doctor has to fill out.
The worms can survive many days without cooling them as long as they do not freez or cook. The delivery is by Express and within 24 hours at the destination also in Ukraine. Because customers order mostly 10 bottles, you have to store them about 5 month and then it is necessary to store them cooled. So do not worry about the delivery.
The price incl. Tax is 3570 €. If you buy 10 bottles, you will get a discount for the further bottles but about the discount we can talk after the 10 dose. Yes the payment is just via Credit Card.
You do not need to stop with the other medication right now. You can take them parallel but after getting in remission, you better should discontinue the other medication in the end of the TSO therapy. This point you have to check with your doctor. You and your doctor can call us everytime you want, we don't desert you!
The Trichuris Trichura or Necator americanus is too dangerous for us and we don't want to have anything to do with them. Fact is that the Trichuris Trichura is the parasite for human beeing and therfore it can survive in us. If it survive, it can go through the blood stream almost all over our body and probably cause the death.
I hope I could answere all of your questions otherwise do not hesitate to contact me again.

Best regards

Morsal
 
Weinstock, Joel [[email protected]]

Dear Igor,

Thank you for writing. I assume you have Crohn's disease for which I am very sorry. The agent that we developed is working its way through both the US and European food and drug administrations. The agent is produced in Europe by a pharmaceutical company called Ovamed. The agent has received GMP approve and is free of other contaminating organisms. I recommend that you check the web site of Ovamed, which can provide more information. A large clinical study is underway in Europe at this time. Best wishes to you and your family.

Regards,

Joel Weinstock
 
So, I buy this 10 bottles of TSO with my Friend! % bottles for me and 5 bottles for my Friend.
Basically TSO did not help us! My Friend with CD could not drink wore then 5 bottels -flare -up. He have to increase prednosolon till 60 per day during TSO treatment.

I could only drink 3 bottles - flare - up. I was in bad situation before and I did not see any changes with TSO and than I was hospitalized.

so this is story regarding TSO!
This is very expensive tretment and I did not believe that this work!

P.S. I have two bottles in my refrigerator, do if somebody wants I can send it!
 
Last edited:
regarding safety:

Dear Igor
QIMR was previously involved in a clinical trial for celiac disease as part of a collaboration with the Princess Alexandra Hospital, Townsville Hospital, Walter and Eliza Hall Institute and the Anton Breinl Centre. The trial involves a small group of healthy people with celiac disease and seeks to establish whether low doses of hookworm larvae can inhibit the immune response responsible for the illness experienced by celiac sufferers. It is hoped that this trial will eventually help to identify new ways of inhibiting autoimmunity and improve the quality of life for people with celiac disease.

There is a second trial coming up, but currently they do not have a start date.
If you wish to be involved please contact Di Jones:
+61 403 757 141
[email protected]

For more information on a range of clinical trials, QIMR would encourage you to consult the Australia and New Zealand Clinical Trial Register (ANZCTR) which is a comprehensive directory of all clinical trials being conducted across Australia and New Zealand. ANZCTR can be found online atwww.anzctr.org.au or +61 2 9562 5333.
Alternatively, you may wish to speak with your GP or medical specialist regarding your potential candidacy for any relevant trials.

Kind regards,
Sarah-Jane
Queensland Institute of Medical Research

Sarah-Jane Matthews
Media Relations Officer | External Relations

Locked Bag 2000, Herston Qld, 4029
300 Herston Road, Herston Qld, 4006
Tel: +61 7 3845 3752 | Mobile: +61 427 364 695 | Fax: +61 7 3362 0102
Email: [email protected]
http://www.qimr.edu.au

Better health through medical research
 
risk of this treatment:
Aditya Reddy [[email protected]]
«..There are some risks in egg preparation and delivery of the egg cocktail per os including the possibility of introducing unknown pathogens associated with the eggs (microbial pathogens). It is difficult to prepare the egg cocktail without assurance that it is pathogen free since bacteria, viruses, small protozoa and even rickettsial organisms have been associated in or on helminth eggs. For this reason and others the egg cocktail procedure has not been approved for use in the USA. It has been used in Mexico and in Europe and could possibly be obtained via mail order..»

CBER OCOD Consumer Account [[email protected]]
Burkoff, Jill [[email protected]]
«…As a follow-up to my last e-mail, I would like to clarify the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) does regulate the use of hookworms for treatment; however, there are currently no approved treatments that use hookworms for the treatment of Crohn’s Disease. As such, FDA is prohibited by the Code of Federal Regulations from disclosing, or even acknowledging any information regarding unapproved products unless the information has already been publicly disclosed by the sponsor or the sponsor has provided written consent for FDA to release such information…»

Steve Stearns [[email protected]]
«..I believe that the Federal Drug Administration in the US prosecuted a British national who was marketing his own hookworm eggs on the web from a base in California. He then left the country. I believe that there is a clinical trial using Trichuris suis eggs being run by a researcher at the University of Iowa medical school. According to US law, people who are not enrolled in clinical trials do not have access to therapy until the outcome of the trial demonstrates that the therapy is effective and not dangerous…»

Robert Summers [[email protected]]
«…Thank you for your note and interest in helminth ova therapy for Crohn’s disease. I appreciate the comprehensive of references for this approach to treatment. At this time, there are two different helminths that have been used to treat inflammatory bowel disease, hookworm and whipworm. Our group has studied Trichuris suis and another group in England has studied hookworm. It is very likely that they both have their effect through a mechanism that is common to both. We feel that the whipworm offers a safer and more predicable option than hookworm, but which one is safer and more effective has not been studied in direct comparison. Although we have conducted the first clinical trial of this form of treatment, we do not currently prescribe treatment because the product has not been approved by the governmental regulatory agencies. A new clinical trial with this agent for Crohn’s disease is being planned in Europe. I would refer you to the web site of a company in Germany that is now producing this therapy: www.ovamed.de. This website has a lot of information about the treatment. It is a good company and its product is GMP approved and it is being used in the clinical studies that are being done.
I hope that this information will be helpful to you. ..»
 
John Croese [[email protected]]

Dear Igor,
Many of the answers to your important questions are as yet not known. In a good laboratory, both NA and TS can be prepared so that the chance of acquiring an unwanted infection should be very small. NA will cause an immediate rash at the inoculation site and a delayed abdominal pain that can last for 3-4 weeks. The early evidence to support using either parasite in Crohn’s is positive, but there has been no convincing follow-up study to prove the case. Given the time that has elapsed since the reports by Weinstock and Croese, it suggests to me that the parasites do not have a role in most cases.
John Croese
 
this my study. Very nice doctor!

Sehr geehrter Herr ХХХХ,

bitte entschuldigen Sie, dass ich erst heute dazu komme Ihnen zu antworten.
· Bitte informieren Sie wann beenden die klinische Studie (TSO für Morbus Crohn) und wann Sie werden die Daten evaluieren? Wie lange wird man TSO bekommen?

Die Studie ist gerade erst angelaufen, es wird rekrutiert bis die erforderliche Anzahl an Patienten eingeschlossen ist, das wird etwa 1 – 2 Jahre dauern.

· Soll man die ganze Zeit in Klinikum bleiben?

Nein, die Studie wird ambulant durchgeführt.

· Wie lange soll ich in Deutschland bleiben um in dieser Studie teilzunehmen? Oder wie oft soll man die Klinikum besuchen? Jeder Monat oder jeder zwei Wochen?

Insgesamt sind 9 Visiten im Verlauf von 13-14 Wochen vorgesehen (Screening, Woche 0, 1, 2, 4, 6, 8, 10, 12).

· Welcher entsprechende Untersuchungen soll man vorhaben oder neu vorbereiten für die TSO Studie?

Diese Frage verstehe ich nicht ganz.


· Welcher Untersuchenden wird man in Deutschland gemacht und welche Kosten lasten auf Patienten, die an der TSO-Studie teilnehmen werden?

Es werden verschiedene Blut- und Stuhluntersuchungen durchgeführt, ggf. auch eine Koloskopie.
Die Teilnahme an der Studie selbst kostet und damit auch an den Untersuchungen kostet den
Patienten nichts.

· Welche negative und positive Folgen von TSO Studien entstehen? Wie werden sie negative Folgen von TSO hindern?

In einer kürzlich durchgeführten Pilotstudie mit TSO wurden folgende Beschwerden berichtet:
Oberbauchschmerzen, Durchfall, Blähungen, Magenschmerzen, Anstieg der eosinophilen Blutzellen, angioneurotisches Ödem.
Mögliche pos. Folgen der Studienteilnahme ist eine Besserung Ihrer Beschwerden durch das Studienpräparat.
Bitte beachten Sie hierzu auch die Abschnitte „Mögliche Risiken und Beschwerden“ sowie „Möglicher Nutzen“ in der beiliegenden Patienteninformation.

· Wie werden Sie kontrollieren der Anzahl von TSO in Patienten im Laufe der Studie?

Die Anzahl der Wurmeier, die verabreicht werden ist standardisiert (250, 2500 oder 7500
Eier). Die Würmer schlüpfen dann im Dünndarm, sind aber nicht lange lebensfähig und sterben
ab. Die Anzahl der Würmer kann nicht gemessen bzw. kontrolliert werden, sondern ist über die
Anzahl der eingenommenen Wurmeier festgelegt.

Ich hoffe Ihre Fragen ausreichend beantwortet zu haben, bin aber jederzeit bereit weitere Fragen zu beantworten. Bitte finden Sie in der Anlage die Patienteninformation für die Studie.


Mit freundlichen Grüßen

Katholische Kliniken Ruhrhalbinsel GmbH
Heidbergweg 22-24
D-45257 Essen

PD Dr. med. Stephan Böhm
Internist – Gastroenterologe
Chefarzt der Klinik für Innere Medizin und Gastroenterologie

Telefon : +49 (0)201 455 1600
Telefax : +49 (0)201 455 2959

Vorsitzende des Aufsichtsrates: Sr. M. Katharina Mock
Geschäftsführer: Martin Blasig

Sitz der Gesellschaft: Essen
Amtsgericht Essen, HRB-Nr. 12918
 
Dear Mr XXXX

you will get first reaction between the 4th and the 6th bottle TSO, that means after 8 or 12 weeks so therefor it is absolut normal that you had no reaction after three days. you need 10 bottle for a complete therapy. Every second week you should drink one bottle.
We alsways send out without cooling them because the eggs will survive a few weeks without cooling them as long as you do not cook or freez them. We also send out for example to Australia and in this case the eggs are on tour for 4-5 days without cooling them and will alive. Please be patient.

Mit freundlichen Grüßen / Best regards

Morsal Haidari
Assistenz der Geschäftsleitung/
Assistent to Managing Director

OVAMED GmbH
Kiebitzhörn 31
22885 Barsbüttel
Tel: +49 40 675 095 10
Fax: +49 40 675 095 59
Email: [email protected]
Web: http://www.ovamed.org

UST-ID-Nr: DE 227 553 335
Geschäftsführer: Alexander Beese, Detlev Goj
Rechtsform: GmbH, Sitz Barsbüttel, Amtsgericht Reinbek HRB 3577
 
Great Thread you guys!!
Thank you for all of your hard work gathering information!
 
Probably not we all had in mind when thinking of a cure for Crohn's, but hey...

Thanks for all that info, Igor!
 
I just want to inform all that we can find in Internet so many positive information regarding TSO! We can find "interesting" people like Helmintictherepie and strange company in UK ( autoimuntherapies)! The most strage Clinic in Mexico. And other videos in Internet regarding this hygiene hypothesis ... Also BBC prepared film But when You spend time, money, talk with doctors... You changing opinion regarding helmints but at the end you have nothing... Againe, againe and againe nothing... Losing your time and IBD progressing! I can say all this company selling this helmints for big money like Humira! Ask why? Where the added value? What they produce? This is all money!!!
 

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