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Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova — MUCUS  

Ulcerative Colitis Clinical Trial

Official title:
Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova

Clinical Trial Summary

The purpose of this study is to understand the immune response activated in the human gastrointestinal tract by Trichuris Suis Ova (TSO) in patients with ulcerative colitis.

Clinical Trial Description

The concept of helminthic therapy (using worms to treat diseases) is supported by experiments in mouse models as well as several clinical studies. TSO, which are purified eggs from the porcine whipworm Trichuris suis, are being investigated in clinical trials as a potential therapeutic agent for the treatment of active Crohn's disease, relapsing multiple sclerosis, peanut and tree nut allergy, and adults with autistic disorders.

The goal of this study is to understand the immune mechanisms activated in the human gastrointestinal tract by treatment with TSO, which may lead to improvements in the symptoms of ulcerative colitis (UC). TSO have been shown to have a clinical benefit on a subset of patients with UC in a previous randomized placebo-controlled trial (Summers et al. 2005). However, the mechanisms of action of TSO on the intestinal mucosa remain unclear.

We propose an exploratory 24-week mechanistic randomized double-blind placebo-controlled crossover study of TSO in patients with established and active UC to better characterize similarities and differences in the immune mechanisms of the intestinal mucosa in response to TSO. We hypothesize that treatment with TSO will lead to an anti-inflammatory immune response in some individuals with UC through an increase in intestinal mucus production and modulation of Th1, Th2, Th17, and T-regulatory effector lymphocyte populations. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01433471
Study type Interventional
Source New York University School of Medicine
Contact
Status Completed
Phase N/A
Start date August 2012
Completion date May 2015
View Details
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