Clinical Trial: Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 Muc

Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC.

Detailed Summary:

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.


Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Current Primary Outcome: 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.


Original Primary Outcome: Percentage of Subjects who Achieve a Clinical Response [ Time Frame: 12 Weeks ]

Clinical response will be defined as a reduction in Mayo score of ≥ 3 and ≥ 30% reduction from baseline, along with either a decrease from baseline in rectal bleeding sub-score of > 1 point or absolute rectal bleeding score of 0 or 1.


Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Percentage of Subjects in Each Study Arm Achieving Remission [ Time Frame: 12 Weeks ]
    Percentage of subjects in each study arm who achieve a remission at Week 12, where remission is defined as Mayo score of ≤ 1 with absence of rectal bleeding and endoscopy score of 0 or 1.
  • Percentage of Subjects in Each Study Arm with Healed Colonic Tissue [ Time Frame: 12 Weeks ]
    Percentage of subjects in each study arm with healed colonic mucosa at Week 12, where healed colonic mucosa is defined as a Mayo endoscopy score of 0 or 1.
  • Time to Reach a Modified Clinical Response [ Time Frame: Up to 12 Weeks ]
    Time to reach a modified clinical response, where modified clinical response is defined as a reduction in the modified Mayo score of ≥ 2 from baseline (i.e., minus the endoscopy component).
  • Percentage of Subjects Each Study Arm with Colonoscopic Evidence of a Visible Worm (luminal or attached) [ Time Frame: Baseline to Week 36 ]
  • Percentage of Subjects Each Study Arm with Increase in Diarrhea [ Time Frame: Baseline to Week 36 ]
    The percentage of subjects experiencing an increase in diarrhea, as measured by the Mayo Score's Stool Frequency score.
  • Percentage of Subjects in Each Study Arm Requiring Increased Medications to Treat UC [ Time Frame: Baseline to Week 36 ]
    Percentage of subjects who require dose-escalation of concurrent medications or need rescue medications to treat UC.


Information By: National Institute of Allergy and Infectious Diseases (NIAID)

Dates:
Date Received: September 24, 2013
Date Started: November 2013
Date Completion:
Last Updated: February 9, 2017
Last Verified: February 2017