Randomized double-blind placebo-controlled crossover study of Trichuris suis ova (TSO) in patients with established ulcerative colitis

[nogutsnoglory]

This is a new trial similar to but more promising than the whipworm trial. A few things went wrong with that trial but NYU finds this one very promising and are encouraged by preliminary results.

http://www.ccfa.org/research/participate-in-research/find-studies-and-clinical-trials/MUCUS.html

 

[Crohn2357]

http://www.ncbi.nlm.nih.gov/pubmed/15825065

Gastroenterology. 2005 Apr;128(4):825-32.
Trichuris suis therapy for active ulcerative colitis: a randomized controlled trial.
Summers RW1, Elliott DE, Urban JF Jr, Thompson RA, Weinstock JV.
Abstract
BACKGROUND & AIMS:
Ulcerative colitis is most common in Western industrialized countries. Inflammatory bowel disease is uncommon in developing countries where helminths are frequent. People with helminths have an altered immunological response to antigens. In animal models, helminths prevent or improve colitis by the induction of regulatory T cells and modulatory cytokines. This study determined the efficacy and safety of the helminth Trichuris suis in therapy of ulcerative colitis.
METHODS:
This was a randomized, double blind, placebo-controlled trial conducted at the University of Iowa and select private practices. Trichuris suis ova were obtained from the US Department of Agriculture. The trial included 54 patients with active colitis, defined by an Ulcerative Colitis Disease Activity Index of > or =4. Patients were recruited from physician participants and were randomly assigned to receive placebo or ova treatment. Patients received 2500 Trichuris suis ova or placebo orally at 2-week intervals for 12 weeks.
RESULTS:
The primary efficacy variable was improvement of the Disease Activity Index to > or =4. After 12 weeks of therapy, improvement according to the intent-to-treat principle occurred in 13 of 30 patients (43.3%) with ova treatment compared with 4 of 24 patients (16.7%) given placebo (P = .04). Improvement was also found with the Simple Index that was significant by week 6. The difference in the proportion of patients who achieved an Ulcerative Colitis Disease Activity Index of 0-1 was not significant. Treatment induced no side effects.
CONCLUSIONS:
Ova therapy seems safe and effective in patients with active colitis.

 

[wild_one353]

Interesting, but definitely not as exciting as fecal transplants. But very much related. The organisms in the intestinal tract, mainly bacteria which 99% of these smaller lifeforms consist of, are doing some pretty interesting things for our well being.

 

[nogutsnoglory]

I don't really see them as similar. One is repopulating the gut with healthy bacteria and the other is forcing the immune system to possibly focus on a real invader ie: ova instead of attacking our gut.

 

[HelenMelb]

Is this still the Coronado product? I notice J. Weinstock listed as one of the authors and he was one of the docs involved in the failed crohn's tso trial.

I tend to agree with wildbill-I think that there is a similarity with fecal transplants. I believe that an unknown infection causes Crohn's, and that fecal transplants can 'crowd it out'. Maybe TSO introduces 'competition' to that same infective agent, rendering it less able to cause damage? Just a thought :smile:

 

[wild_one353]

I don't really see them as similar. One is repopulating the gut with healthy bacteria and the other is forcing the immune system to possibly focus on a real invader ie: ova instead of attacking our gut.

ok ill explain a bit then.

without getting way to technical, generally it is stated that these whip worms can induce regulatory t cells, which in very general non specific terms, can turn the immune system "off".

Here is a quote from wikipedia-

Regulatory T cells come in many forms with the most well-understood being those that express CD4, CD25, and Foxp3 (CD4+CD25+ regulatory T cells, or "Tregs").[1] These cells are involved in shutting down immune responses after they have successfully eliminated invading organisms,

so if all that is true, then these whip worms cannot clearly be classified as pathogenic organisms if they produce some benefit like that to its host.

This same ability to induce t reg cells is also shared with good bacteria in the gut. So then, if all the above is true, then my claim that "it is like a fecal transplant", is generally true.

 

[Igor_Passau]

again this!! My friend and me tried this TSO. We receiver it from Ovamed ( german company). Did not work for us!!!

 

[nogutsnoglory]

I heard an expert say it's not the exact same trial and that this one was promising. I don't really understand the difference.