A prospective, multicenter, randomized controlled trial comparing fecal microbiota transplantation (FMT) to placebo in the treatment of active pouchitis

IMAGINE’s Mind and Gut Interactions Cohort is a prospective observational cohort study looking at the interactions between inflammation, gut bacteria, and diet in order to better treat Irritable Bowel Syndrome (IBS) and Inflammatory Bowel Disease (IBD, which includes both ulcerative colitis and Crohn’s disease), and to understand their link to mental health. www.imaginespor.com

The CONCLUDE Study will compare the safety and efficacy of an investigational medication, called cobitolimod, with a placebo in patients with moderate to severe active left-sided UC.  Eligible participants will be randomly assigned in a 1:1:1 allocation to receive either cobitolimod or placebo via rectal enema every third week. The study will last up to 52 weeks (excluding screening) and involve 440 participants in around 200 study centers across the world.

The primary objective of this trial is to determine whether, in subjects with moderately to severely active UC, treating to achieve a target of corticosteroid-free symptomatic + endoscopic + histological remission is superior to a treatment target of corticosteroid-free symptomatic remission, with regards to a primary endpoint of time to UC-related complication within up to 80 weeks of follow-up after achieving target. Treatment algorithms will feature the use of Vedolizumab after certain key assessment points.  A key premise is that vedolizumab has a favorable safety profile and can be safely and effectively used to treat subjects who are in symptomatic remission but who have not attained endoscopic or histological remission. They will receive IV Vedo for up to a year and if they are doing well will have the option for a second year on IV or s/c Vedo. 

This is an open label study with all UC patients receiving FMT.
Primary objectives: Suitability of FMT donors at inducing remission in active UC (remission defined as a Mayo score (7) < 3 with an endoscopic Mayo score = 0 at the end of 8 weeks of FMT).

Maintenance of remission of UC after three years in those who achieve initial remission with FMT.  This is defined as no relapse over three years that requires any medical therapy other than more intense FMT therapy.