# Is a cure for Crohn's disease in sight?



## armen

One researcher believes he may have found a cure for Crohn's disease, reports Kathleen Blanchard of EmaxHealth.com. 

Dr. Saleh Naser of the University of Central Florida (UCF) has devoted the past 18 years trying to find a cure for the disease that affects more than 750,000 Americans.

In a press release published September, 2013, Naser announced a Phase III clinical trial that uses an antibiotic that removes a bacterium thought to cause Crohn's disease inflammation.

High hopes for a Crohn's disease cure

The drug company RedHill Biopharma, has licensed Naser’s DNA technology for detecting the bacteria associated with Crohn's disease, known as Mycobacterium avium subspecies paratuberculosis - or MAP, which Naser believes is the cause of the disease.

Naser however says he has seen cases where people's lives have been completely restored following the treatment that is an anti-MAP antibiotic regimen known as RHB 104.

Red Hill BioPharma says a second phase III clinical trial of the treatment is set to be launched the first half of this year in Europe. The first phase III trial was started in September, 2013 in Israel and the United States.

Naser says the drug regimen is different than current treatments with drugs because it addresses the problem rather than the symptoms.

*A caveat: Does MAP really cause Crohn's?*

Whether or not the bacteria is the underlying cause of the inflammatory bowel disease (IBD) has been the subject of debate. MAP is known to cause a variety of intestinal inflammatory disease in animals.

Infected humans that develop Crohn's disease or ulcerative colitis could contract the bacteria from contaminated milk, water or products made with milk contaminated with MAP. (or so researchers speculate).

Other possibilities include inhalation or infection from contaminated rivers. In all cases, animals exposed to MAP by any route develop intestinal disease.

Dr. Naser and his team will test patients for one year to monitor for the presence of MAP in the blood and intestines of 240 people with Crohn's disease before, during and after the study.

Naser says the study should put to rest a 100 year old debate about what causes Crohn's disease. "I have high hopes that this clinical trial may lead to finding a cure," Naser said.


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## JMC

I believe we are close to a cure for Crohns and Dr Saleh Naser has done some great work proving the link between Crohns and MAP. His approach to a cure is to use a combination of antibiotics, but a more sophisticated solution, a vaccine against MAP has been developed by a research team in London. This vaccine now needs to be clinically trialled: http://crohnsmapvaccine.com


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## sid

All the best to Dr naser.
So many researches are going on around the world..am sure the hard work will pay and we'll see some breakthrough very soon.


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## Axelfl3333

I,m a believer in flinging a lot of money at a problem,it eventually will stick.


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## JMC

Threads like this puzzle me, surely a cure for Crohns should be of interest to everyone on this forum and yet there are only 3 replies.  This is HUGE news, why are people not taking it seriously?


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## xmdmom

Here is more info about the clinical trial. Click on study locations if you are interested. They are still recruiting.  http://clinicaltrials.gov/ct2/show/study/NCT01951326?show_locs=Y#locn


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## Reef08

My guess is there'll be a cure in around 20 years.


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## JMC

Reef08 said:


> My guess is there'll be a cure in around 20 years.


If MAP is proven, unquestionably, to be the cause of Crohn's which I expect to happen in the next 12 months, we have antibiotic treatments _right now_ that can cure it in the short term and a vaccine, which just needs to complete human trials which could be a permanent cure.  We are not 20 years away, it is more like 3 years.  Only a lack of funding is holding things back.


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## xmdmom

It may turn out that MAP is one cause of Crohn's or one exacerbating factor.


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## Reef08

JMC said:


> If MAP is proven, unquestionably, to be the cause of Crohn's which I expect to happen in the next 12 months, we have antibiotic treatments _right now_ that can cure it in the short term and a vaccine, which just needs to complete human trials which could be a permanent cure.  We are not 20 years away, it is more like 3 years.  Only a lack of funding is holding things back.


Antibiotics are not a permanent cure. They don't prevent the infection; they only eliminate the current infection. 

It's like when you take antibiotics for an ear infection. They won't prevent you from getting more ear infections in the future. I was on the Anti-MAP protocol and it did nothing for me, except trigger Celiac disease in addition to the Crohn's. If (and it's a big if), the theory is true, and the vaccine is finally developed, maybe then we'll see a permanent cure, but that'll take another 10 years to go through clinical trials.


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## JMC

xmdmom said:


> It may turn out that MAP is one cause of Crohn's or one exacerbating factor.


It may turn out that what we understand as Crohn's is not a single disease, but I think the evidence increasingly is pointing at MAP for the vast majority of cases.  Now we have accurate tests for MAP any doubt over this will be eliminated.  I am also told preliminary results using a test that _is accurate for human MAP_  has showed 100% of Crohn's patient tissue samples were infected.  The tissue samples from my 2012 resection will be tested in the coming weeks, I will let you know the results.  

I don't think there is any evidence MAP is just an exacerbating factor, it will be the _cause_ (or not).  If there are any research papers to support that is is just an exacerbating factor can you please send me the links as I am trying to read absolutely everything on this subject at the moment.


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## JMC

Reef08 said:


> Antibiotics are not a permanent cure. They don't prevent the infection; they only eliminate the current infection.


Note, I did not say antibiotics are a long term cure.



Reef08 said:


> I was on the Anti-MAP protocol and it did nothing for me, except trigger Celiac disease in addition to the Crohn's. If (and it's a big if), the theory is true, and the vaccine is finally developed, maybe then we'll see a permanent cure, but that'll take another 10 years to go through clinical trials.


Who administered the drugs and what did you take?  Were you first tested to establish that you were MAP+ (and how?)  

I think, if you read all of the papers, you will see it is not a big if.  It is more of a big _why_?  Why have we taken so long to confirm or disprove Crohns is a MAP infection.


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## xmdmom

No evidence just conjecture ...

Google scholar is a good way to find scholarly papers on a topic.


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## Reef08

JMC said:


> Note, I did not say antibiotics are a long term cure.
> 
> 
> 
> Who administered the drugs and what did you take?  Were you first tested to establish that you were MAP+ (and how?)
> 
> I think, if you read all of the papers, you will see it is not a big if.  It is more of a big _why_?  Why have we taken so long to confirm or disprove Crohns is a MAP infection.


Dr. Chamberlin from Texas spoke with my doctor who prescribed the drugs for me. I wasn't tested for MAP, because there's no commercial test available. 

I've read all the papers, and the theory is very provocative, but so far the trials don't show any long-term benefits. I don't believe it's the cause anymore. I'm leaning more towards leaky gut/dysbiosis, but that's just my opinion. 

When we don't even know the answer to basic research like this, it shows how far away we are from a cure. 

There is an actual permanent cure available now, but it's not safe or feasible: allogeneic stem cell transplants.


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## Poppysocks

Reef08 said:


> Dr. Chamberlin from Texas spoke with my doctor who prescribed the drugs for me. I wasn't tested for MAP, because there's no commercial test available.
> 
> I've read all the papers, and the theory is very provocative, but so far the trials don't show any long-term benefits. I don't believe it's the cause anymore. I'm leaning more towards leaky gut/dysbiosis, but that's just my opinion.
> 
> When we don't even know the answer to basic research like this, it shows how far away we are from a cure.
> 
> There is an actual permanent cure available now, but it's not safe or feasible: allogeneic stem cell transplants.


The anti-biotics are not the solution in my opinion. They don't even work for all of the animals that are infected with MAP they're not going to work with every human either. That's why a vaccine is a 10x better solution to this.

Either way. It's been WAYYY too long for this theory to still not have been SERIOUSLY looked into. Crohns patients deserve a definitive answer on this. NOW. Not 5 years, or 10 years, 20 years from now. They need to prove it or disprove it NOW.


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## JMC

Reef08 said:


> I've read all the papers, and the theory is very provocative, but so far the trials don't show any long-term benefits.


Sorry, but that is not correct.  Have you watched this lecture?  

There is a 2014 update from Marcel Behr (recorded on 28th May) which should be available in the next few weeks.


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## JMC

Reef08 said:


> There is an actual permanent cure available now, but it's not safe or feasible: allogeneic stem cell transplants.


What evidence is there that this is a cure?


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## Reef08

JMC said:


> What evidence is there that this is a cure?


It's a very small sample size since these were Crohn's patients that developed blood cancers that required transplants: 

http://www.ncbi.nlm.nih.gov/pubmed/9496932

There are trials going on right now for those with severe Crohn's. An allogeneic transplant allows the recipient to obtain the immune system genes of the donor, thereby removing the susceptibility to Crohn's.


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## Reef08

JMC said:


> Sorry, but that is not correct.  Have you watched this lecture?
> 
> There is a 2014 update from Marcel Behr (recorded on 28th May) which should be available in the next few weeks.


I watched that video a long time ago.  I'll watch it again when I have some time. 

I remember following this trial: http://www.ncbi.nlm.nih.gov/pubmed/17570206
More of the patients on the actual drug relapsed compared to those on placebo after one year. 

Also, Redhill Biopharma's antibiotic protocol only produced a median remission length of 16 months: http://ir.redhillbio.com/releasedetail.cfm?ReleaseID=797192


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## Reef08

Poppysocks said:


> The anti-biotics are not the solution in my opinion. They don't even work for all of the animals that are infected with MAP they're not going to work with every human either. That's why a vaccine is a 10x better solution to this.


I agree, but by the time the vaccine is funded and gone through clinical trials, we're looking at easily over 10 years. That's assuming the theory is true.


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## JMC

Reef08 said:


> I remember following this trial: http://www.ncbi.nlm.nih.gov/pubmed/17570206
> More of the patients on the actual drug relapsed compared to those on placebo after one year.


The often quoted and unfortunately flawed study


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## Malgrave

Reef08 said:


> I've read all the papers, and the theory is very provocative, but so far the trials don't show any long-term benefits. I don't believe it's the cause anymore. I'm leaning more towards leaky gut/dysbiosis, but that's just my opinion.


Please take a look at the infographic below: MAP causes leaky gut which in turn causes the massive inflammation.

http://crohnsmapvaccine.com/wp-content/uploads/2014/06/MAP-infographic-portrait.pdf


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## glum chump

There may well be a network of complicating factors that contribute to Crohn's, and I do believe that MAP might significantly contribute to the onset and trajectory of Crohn's Disease in some people. For a number of years now, I've been hopeful that researchers might be able to unlock/isolate a set of antibiotics that they could then calibrate in terms of combination and dosage that could attack the MAP bacteria.

A number of years back, I was having a rough time with the Cipro/Flagyl combination and I went to my GP. He wasn't there, and the replacement doctor that I saw prescribed me Clarithromycin and Clindamycin. I don't know how it happened, but I went into remission for almost two years. I didn't realize at the time that Clarithromycin was one of the drugs that, at the time, was being researched for MAP. My GI has been ambivalent of the link between MAP and Crohn's, but had allowed me to pursue this combination of antibiotics since the first time (with caution since they can also bring on C. difficile), but the drugs haven't been as successful as the first time. However, each time, it alleviates the severity of my symptoms. I really wanted to try Rifabutin and Clindamycin combination, but Rifabutin was not available in Canada. 

In a field littered with biologics as a 'go-to' treatment for Crohn's for a long time -- which works for some and not for others -- the research work of Dr. Naser might well be a source of relief from Crohn's disease (and if not the disease, at least the debilitating symptoms) for a number of us. I, for one, look forward to the unfolding of MAP-based research for Crohn's and look forward to the availability of the vaccine to try out. 

Cheers,

Kismet


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## JMC

glum chump said:


> In a field littered with biologics as a 'go-to' treatment for Crohn's for a long time -- which works for some and not for others -- the research work of Dr. Naser might well be a source of relief from Crohn's disease (and if not the disease, at least the debilitating symptoms) for a number of us. I, for one, look forward to the unfolding of MAP-based research for Crohn's and look forward to the availability of the vaccine to try out.


My big issue with biologics is that they are not addressing the underlying cause of the disease and never will, not to mention the fact that they can have very toxic side effects.  They are a pharmaceutical companies dream, which is why they keep developing more, but definitely not in the best interests of the patient.


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## nogutsnoglory

I think we will see a cure in my lifetime but maybe not for everyone since I think we will learn that there are different causes of IBD.


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## xeridea

What do you all think about the school of thought that believes Crohn's is an auto-inflammatory rather than auto-immune condition? The proposition being that one or more genetic mutations result in a deficient immune response to clearing bacteria in the bowel, and so a persistent inflammatory response is mounted in an ultimately unsuccessful effort to clear the antigens. Maybe the differing degree and combination of involvement of the mutations among the NOD2 / CARD15 / ATG16L1 / IRGM / IL-?? genes implicated in CD accounts for the difference in how the disease manifests itself among people.

If it were the case that MAP was a culprit in the onset of the disease, then MAP abx cocktail therapy may clear that particular instance of the infection, but because of the immune deficiency, upon re-exposure to the bacteria, the infection can easily come back. That's where Prof. Herman-Taylor's vaccine may help prevent relapse. I might point out that one study suggests Infliximab (Remicade) can impede survival of MAP in the gut (see Journal of Crohn's and Colitis (2012) 6, 628–629). I'd be interested if there were any studies looking at long term impact of combination anti-MAP/Remicade therapy on the course of the disease.

Or if the offending bacteria is AIEC, then something like the SSI vaccine (currently in trials) would help.

But who knows if these are the only two suspects. I believe some new research tied to the Microbiome project will look at a dozen or so bacteria as possible suspects, and perhaps develop treatments specific for them.

In the short-term, we need accurate diagnostic tools to identify the offenders so a custom treatment plan could be devised to tackle specific bacteria.

Ultimately though, it seems the promise of a cure lies in advances that would correct the faulty genes and restore an effective immune response. I'm holding out hope for safe and effective stem cell therapy to deliver this.


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## JMC

CrohnsForum said:


> What do you all think about the school of thought that believes Crohn's is an auto-inflammatory rather than auto-immune condition? The proposition being that one or more genetic mutations result in a deficient immune response to clearing bacteria in the bowel, and so a persistent inflammatory response is mounted in an ultimately unsuccessful effort to clear the antigens. Maybe the differing degree and combination of involvement of the mutations among the NOD2 / CARD15 / ATG16L1 / IRGM / IL-?? genes implicated in CD accounts for the difference in how the disease manifests itself among people.


I believe Crohn's is not an auto-immune disease and agree with your assessment that it is an immune deficiency with clearing bacteria.  NOD2/CARD15 /ATG16L1/IRGM are all implicated in the identification and elimination of mycobacteria by your immune system.



CrohnsForum said:


> If it were the case that MAP was a culprit in the onset of the disease, then MAP abx cocktail therapy may clear that particular instance of the infection, but because of the immune deficiency, upon re-exposure to the bacteria, the infection can easily come back.


Agreed



CrohnsForum said:


> That's where Prof. Herman-Taylor's vaccine may help prevent relapse.


Agreed



CrohnsForum said:


> I might point out that one study suggests Infliximab (Remicade) can impede survival of MAP in the gut (see Journal of Crohn's and Colitis (2012) 6, 628–629). I'd be interested if there were any studies looking at long term impact of combination anti-MAP/Remicade therapy on the course of the disease.


Prof Hermon-Taylor has some interesting (and as yet unpublished research) showing the impact of immune modulators on MAP infection.



CrohnsForum said:


> Or if the offending bacteria is AIEC, then something like the SSI vaccine (currently in trials) would help.


Again, agree with this



CrohnsForum said:


> But who knows if these are the only two suspects. I believe some new research tied to the Microbiome project will look at a dozen or so bacteria as possible suspects, and perhaps develop treatments specific for them.


I am not convinced, we need a model for how those other bacteria would cause Crohn's like symptoms.  I think the Microbiome project is too vast and not specific enough to yield useful results.



CrohnsForum said:


> In the short-term, we need accurate diagnostic tools to identify the offenders so a custom treatment plan could be devised to tackle specific bacteria.


Absolutely, which is why a high quality MAP diagnostic test is equally as important as the vaccine



CrohnsForum said:


> Ultimately though, it seems the promise of a cure lies in advances that would correct the faulty genes and restore an effective immune response. I'm holding out hope for safe and effective stem cell therapy to deliver this.


Maybe


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## Momtotwo

JMC- Where will your specimen be tested? Was it difficult to find someone to test for MAP? (If i missed those details and the were already posted, I apologize.)


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## mish2575

JMC said:


> If MAP is proven, unquestionably, to be the cause of Crohn's which I expect to happen in the next 12 months, we have antibiotic treatments _right now_ that can cure it in the short term and a vaccine, which just needs to complete human trials which could be a permanent cure.  We are not 20 years away, it is more like 3 years.  Only a lack of funding is holding things back.


Even if they figure it out with this trial it will take many many years for it to happen - IF the pharma lobbyists don't stop it somehow.  The politics involved are unbelievable.  


Serious question. . . . when is the last time a "cure" for a major disease was administered?  The flu, maybe?  That is only because it makes money - most people get the vaccine every year.


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## Momtotwo

CrohnsForum said:


> What do you all think about the school of thought that believes Crohn's is an auto-inflammatory rather than auto-immune condition?
> 
> CrohnsForum- Do you have any good resources for that theory? I would like to read more, but I tend to find that info on sites I don't necessarily trust.


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## mish2575

I don't understand how it can be an auto-inflammatory, rather than auto-immune disease when there are so many extra-intestinal manifestations with this disease, not all include inflammation. . . psoriasis, for example.

Granted, most of my extra-intestinal manifestations ARE inflammatory:
Episcleritis
Psoriasis
Hidradenitis


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## JMC

Momtotwo said:


> CrohnsForum said:
> 
> 
> 
> What do you all think about the school of thought that believes Crohn's is an auto-inflammatory rather than auto-immune condition?
> 
> CrohnsForum- Do you have any good resources for that theory? I would like to read more, but I tend to find that info on sites I don't necessarily trust.
> 
> 
> 
> Yes, the best one if Marcel Behr's 2010 lecture on Youtube
> 
> And this one from Thomas Barody
> [youtube]vCVt7eZNqhk[/youtube]
Click to expand...


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## JMC

Another excellent interview on MAP/Crohns with Thomas Borody.  It is in 9 parts, it is worth watching from start to finish.
[youtube]crm4pKz6X2M[/youtube]

In case you are questioning the credibility of Thomas Borody vs what your gastroenterologist may tell you, let's look at his Wikipedia entry:

"As a gastroenterologist, _*Borody *_is most famous for his work on the development of the _*triple therapy for infection with Helicobacter pylori*_ bacteria. The triple therapy, which was invented around 1987, is a combination of bismuth, metronidazole and tetracycline. At the time, Borody was working with _*Dr. Barry Marshal and Dr. Robin Warren*_ (who later received a _*Nobel prize*_ for their research into Helicobacter pylori), and is considered to be the first physician to successfully formulate the triple therapy that would later become the gold standard for treating peptic ulcer disease caused by Helicobacter pylori infection."

This guy is 100% certain MAP is the cause of Crohn's disease, he does not even consider there is any argument about it.


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## Axelfl3333

hope this guy is right!but why no cure yet?


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## xeridea

> Momtotwo - Do you have any good resources for that theory? I would like to read more, but I tend to find that info on sites I don't necessarily trust.


As new user site rules prevent me from posting URLs, but Google the term "Crohn’s Disease: an Immune Deficiency State Daniel J. B. Marks, Farooq Z. Rahman, Gavin W. Sewell, Anthony W. Segal" and you should see a PDF research paper you can read through.

Also Google "Revisiting Crohn's disease as a primary immunodeficiency of macrophages. Jean-Laurent Casanova and Laurent Abel" for another paper.

The reason I believe CD is an immuno-deficiency is that I am caregiver to young teen ds, who as a young child would get infections that pediatrician would off-hand comment was out of norm. We didn't think much of it at the time since we would treat it and move on. But in retrospect, I now think that  a deficient immune system may have been the root of why he would come down with the different infections.



> Mish2575 - I don't understand how it can be an auto-inflammatory, rather than auto-immune disease when there are so many extra-intestinal manifestations with this disease, not all include inflammation. . . psoriasis, for example.


I'm sorry, I don't know the answer off hand. The only thing I can think of is that when CD is active there is increased levels of circulating cytokins throughout the body. I have to do some research to see if these somehow correlate to EIM, or maybe there is some other mechanism at play.

Mish2575 - 





> Serious question. . . . when is the last time a "cure" for a major disease was administered? The flu, maybe? That is only because it makes money - most people get the vaccine every year.


 And speaking out of place here since this comment was directed at JMC, but I have absolute faith in mankind's greed to come up with a cure for this terrible disease. Case in point. Sovaldi, the recently introduced drug holding great promise for treating Hepatitis C. It has astronomical costs justified by the maker as the steep costs involved in developing the drug. The prices may stick for a year or two as policies are debated and it may ultimately be beaten down to more reasonable levels. I think a cure for CD will ultimately be found within the next decade, and will come at a high cost, similarly justified. But balance that against the costs of current maintenance medication, and add the cost of treating complications, and I think that very expensive cure will be a bargain compared to the cost of current lifelong therapies.


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## JMC

xeridea said:


> As new user site rules prevent me from posting URLs, but Google the term "Crohn’s Disease: an Immune Deficiency State Daniel J. B. Marks, Farooq Z. Rahman, Gavin W. Sewell, Anthony W. Segal" and you should see a PDF research paper you can read through.


Interesting paper, but if you agree with Thomas Borody/Marcel Behr/John Hermon Taylor/Saleh Naser (which I do) it contains a number of errors




xeridea said:


> Also Google "Revisiting Crohn's disease as a primary immunodeficiency of macrophages. Jean-Laurent Casanova and Laurent Abel" for another paper.


This is consistent with the MAP theory if I understand it correctly


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## kiny

yes, there is something different with our innate immune system, at least for people carrying NOD2 or ATGL16 variants
since our intestines are filled with macrophages, this is very relevant to our disease, macrophages are part of the innate immune response, NOD2 and ATG16L1 are both required for autophagy and the clearance of microbes, if our macrophages can't do that they would seek other methods and increase phagocytosis. But macrophages aren't just responsible for clearing bacteria, they serve as antigen presenting cells and induce cytokine, if our innate immune system is incapable of clearing certain bacteria, a cascade of inflammation would ensue.

it doesn't therefore mean that MAP is involved, it just means that it is crystal clear our disease is related to bacteria, because all the genetic risk variants are related to bacterial handling


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## mish2575

xeridea said:


> . I think a cure for CD will ultimately be found within the next decade, and will come at a high cost, similarly justified. But balance that against the costs of current maintenance medication, and add the cost of treating complications, and I think that very expensive cure will be a bargain compared to the cost of current lifelong therapies.


I pray that you are right. I'm just the type of person that doesn't get my hopes up, not that I'm a negative person in nature, I just don't set myself up for disappointment.


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