Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis
Biological: Trichuris suis ova (TSO)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official 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|
- Percentage of Participants Who Achieved a Clinical Response at Week 12 [ Time Frame: Week 12 ]Clinical response is defined as a reduction in the Mayo score of at least 3 points and at least a 30% reduction from Baseline, along with either a decrease from Baseline in the rectal bleeding subscore of more than 1 point or a rectal bleeding subscore of 0 or 1.
- Percent of Participants Who Achieved Remission at Week 12 [ Time Frame: Week 12 ]Remission is defined as a Mayo score of less than or equal to 1 with absence of rectal bleeding and endoscopy score of 0 or 1.
- Percent of Participants With Healed Colonic Mucosa at Week 12 [ Time Frame: Week 12 ]Healed colonic mucosa is defined as a Mayo endoscopy score of 0 or 1.
- Percent of Participants With a Modified Clinical Response [ Time Frame: From Day 0 through time of first clinical response or end of follow-up, whichever comes first, up to 12 Weeks ]Modified clinical response is defined as a reduction in the modified Mayo score (i.e., minus the endoscopy component) of at least 2 points from baseline.
- Time to Modified Clinical Response [ Time Frame: From Baseline through the day that modified clinical response is reached. Week 16 is the last visit that the modified Mayo score is assessed. ]Number of days to reach a modified clinical response. Modified clinical response is defined as a reduction in the modified Mayo score (i.e., minus the endoscopy component) of at least 2 points from baseline.
- Percent of Participants With Colonoscopic Evidence of Visible Worm [ Time Frame: From Day 0 through end of follow-up, up to 36 weeks ]Stool evaluations for ova and parasites confirmed the absence of T. suis. If evidence suggested a presence of T. suis, a colonoscopy would be performed to confirm invasion with a visible worm.
- Percent of Participants With Increase in Diarrhea [ Time Frame: From Day 0 through end of follow-up, up to 36 weeks ]An increase in diarrhea is defined as an increase in the Mayo Score's Stool Frequency score by at least 1 point from baseline at any time during follow-up.
- Percent of Participants With Increase in Concurrent Ulcerative Colitis (UC) Medications or New Rescue Medications Added [ Time Frame: From Day 0 through Week 16 ]New or increase in UC medications is defined as a need for dose-escalation of concurrent medications or need for rescue medications to treat UC through Week 16.
|Study Start Date:||November 2013|
|Study Completion Date:||November 2015|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Trichuris suis ova (TSO)
Six doses of TSO orally over a ten-week period
Biological: Trichuris suis ova (TSO)
Six doses of TSO orally over a ten-week period (e.g., every 2 weeks x 10 weeks for a total of 6 total doses)
Placebo Comparator: Placebo
Six doses of TSO placebo orally over a ten-week period
Six doses of TSO placebo orally over a ten-week period (e.g., every 2 weeks x 10 weeks for a total of 6 total doses)
Other Name: Trichuris suis ova (TSO) placebo
The cause of UC, an inflammatory bowel disease (IBD), is not well understood. It is believed to be caused from an abnormal immune response to the normal bacteria that live in the gut (intestines and colon). This response acts as an "attack" on the healthy tissue of the bowel by a person's own immune cells which leads to disease.
It is well known that autoimmune diseases such as IBD, asthma, diabetes, and multiple sclerosis are more common in industrialized, well-developed countries with better sanitation and hygiene, as in the United States. These "cleaner" environments reduce exposure to germs and parasites naturally found in the environment. This reduced exposure may trigger responses in the body that make people more prone to diseases such as UC. People in non-industrialized countries and the tropics, where parasites are common, rarely develop these diseases. This observation has led researchers to want to better understand the relationship between the lack of natural bacteria in the gut and the onset of autoimmune diseases like as UC.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01953354
|United States, California|
|Stanford University School of Medicine|
|Palo Alto, California, United States, 94305|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06510|
|United States, Florida|
|University of Miami Miller School of Medicine|
|Miami, Florida, United States, 33136|
|United States, Illinois|
|Northwestern University Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Iowa|
|University of Iowa Hospital|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|University of Maryland|
|Baltimore, Maryland, United States, 21201|
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10021|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19103|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37212|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|Study Chair:||Stephen Hanauer, MD||Northwestern University|
|Study Chair:||Bana Jabri, MD, PhD||University of Chicago|