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Trichuris suis ova (TSO) in Ulcerative Colitis


Title A Prospective, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study of Trichuris suis Ova Treatment in Left-sided Ulcerative Colitis and its Effects on Mucosal Immune State and Microbiota
Therapeutic Area Ulcerative Colitis
Principal Investigator Harmony Allison, MD
Min Age 18 Years
Gender Both
Contact Glenna Regan
617-636-0653
More Information clinicaltrials.gov/ct2/show/NCT01953354

Overview

Research has been done to look at the effect of a tiny parasitic worm, Trichuris suis (TSO), in the gut on various diseases which include allergic rhinitis (hay fever), multiple sclerosis, and IBD (Crohn’s disease and ulcerative colitis). TSO is about the size of an eyelash, and its natural host (the place the parasite normally lives) is the pig. The worm cannot live for more than a few months in a human intestine. When a human ingests the microscopic eggs of this worm, the eggs hatch inside the intestine and temporarily take up residence there. The researchers doing this study think that the worms may “distract” the immune system so that it fights the worm rather than targeting the colon. Researchers hope this will decrease the symptoms of the disease and even put it in remission for a period of time.

The purpose of this study is to evaluate the safety and effectiveness of TSO in ulcerative colitis. We will look at how TSO affects the body’s immune response and if there are changes in disease. 

Study Details

Inclusion Criteria

  • Adult male and non-pregnant, non-lactating female subjects, ≥18 years of age, based on the date of the screening visit
  • Diagnosis of Ulcerative Colitis as determined by medical history with proximal disease extent limited to the left colon

Exclusion Criteria

  • Uncontrolled GI bleeding
  • Subjects who have disease limited to the rectum
  • History of colonic dysplasia

Study Requirements

The screening/baseline phase may have 2 visits over a 1 month period to determine if you qualify to participate in this study and to evaluate your baseline disease condition. There is also a treatment period that will include 6 visits over 12 weeks and a follow-up period that will include 2 visits over a 1 month period. Your total time involved in the study once treatment begins is 36 weeks (a little less than 9 months).

During the screening/baseline visits, you will provide a stool sample and have a sigmoidoscopy with biopsies. Blood will be drawn at each visit to see how you are responding to the treatment. During the entire 36 weeks of the study, approximately 80 mL (approximately 5.5 tablespoons) of blood will be drawn.