Clinical Trials

The purpose of this study is to assess the safety, tolerability, and effectiveness of AMT-101 in subjects with chronic antibiotic-resistant pouchitis, and to select an AMT-101 dose for Phase 3.

A Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic antibiotic refractory pouchitis. Subjects will undertake a <2 week screening period to provide baseline data and be assessed for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1 basis to either a) 240 mg alicaforsen enema or b) matching placebo. Study drug will be administered once nightly (on going to bed) up to and including week 6. Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy assessments at Week 3, 6, 10, 18 and 26. Subjects ...

The purpose of this study is to learn more about the bacteria that live in the small and large intestine and the role that these bacteria play in causing inflammation in the gastrointestinal tract.

The purpose of this study is to find out if there is a relationship between pouch function (the ability to completely evacuate or empty the pouch) and the development of inflammation in the pouch.

The purpose of this study is to determine normal values of anorectal manometry (ARM) in asymptomatic patients with an ileal pouch-anal anastomosis (IPAA), and to compare pouch evacuation dynamics between those who are asymptomatic with assumed normal pouch function and those with symptoms suggestive of a pouch evacuation disorder. 

The primary purpose of this study is to establish an Arizona-based patient recruitment and sample collection infrastructure with a wide network of gastroenterologists in Maricopa County, including both academic and community gastroenterologists.  Secondarily, they will analyze the pouch microbiota and anti-microbial antibodies in longitudinal samples collected from patients undergoing RPC with IPAA.  We will compare data from patients who develop pouchitis and those who do not develop pouchitis to eventually identify antibody markers that can prognosticate pouchitis and understand the role of bacteria or immune response to them in pouchitis development. 

The primary purpose of this study is to create a prospective registy of patients with pouch-related conditions to allow for longitudinal assesment of outcomes at 3, 6 and 12 months after a enrollment with a specific diagnosis ( CARP or CD of the pouch). 

The main objective is to compare prebiotic therapy with placebo for the prevention of pouchitis after closure of diverting ileostomy in patients with an ileal pouch anal anastomosis. This study will also characterize the effects of prebiotics on the fecal microbiota and fecal microbial metabolites and correlate these effects with the primary outcome of development of pouchitis.

The purpose of this study is to assess the efficacy and safety of vedolizumab intravenous (IV) in participants with a proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis (UC) who have developed chronic or recurrent pouchitis, or require continuous antibiotic treatment.

The primary purpose of this study is to create a prospective registry of patients with pouch-related conditions to allow for longitudinal assessment of outcomes at 3, 6 and 12 months after a enrollment with a specific diagnosis (acute pouchitis, CADP, CARP, or CD of the pouch).