Safety and Efficacy of Fecal Microbiome Transplantation (FMT) in the Treatment of Antibiotic Dependent Pouchitis (ADP)

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Pouchitis

In brief

Antibiotic dependent pouchitis (ADP) is predestined to benefit from FMT, since bacterial dysbiosis, which can only be controlled with antibiotics, appears to be the major driver of the clinical symptoms. This is a proof of concept randomized placebo controlled trial, in which 50% of the patients will receive FMT and 50% will receive a placebo FMT. Additionally the trial offers an open label extension period.

Key facts

Study ID

NCT02782325

Run by

University of North Carolina, Chapel Hill

People needed

6

Starts

2017-06-01

Expected to finish

2018-12-03

Last updated by the study team

2019-05-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent.
• Man or woman between 18 and 70 years of age.
• Ileal Pouch-Anal Anastomosis (IPAA) after colectomy for ulcerative colitis
• Active pouchitis, defined as a modified pouch disease activity index (mPDAI) ≥ 5 and a history of ≥ 4 antibiotic therapies for pouchitis in the last 12 months
• or
• Need for ongoing antibiotic therapy (> 4 weeks) to maintain clinical remission and a history of at least 2 attempts in the last 24 months to stop antibiotic therapy resulting in pouchitis episodes.

You may not qualify if…

• Treatment with biologics (e.g. infliximab, adalimumab, golimumab, vedolizumab)
• Treatment with immunomodulators (azathioprine, 6-mercaptopurine (6-MP), methotrexate), steroids or any investigational drugs
• Use of cholestyramine
• Crohn's disease of the pouch
• Known cytomegalovirus infection of the pouch
• Clostridium difficile infection
• Isolated cuffitis
• Clinical significant strictures of the pouch inlet or outlet
• Concurrent intestinal obstruction
• History of familial adenomatous polyposis
• History of uncontrolled lactose intolerance
• History of confirmed (serological test and/or histology) celiac disease
• Pregnancy, breast feeding, or planning to become pregnant during the trial
• Non - steroidal inflammatory medications (NSAIDs) as long-term treatment, defined as use for at least 4 days a week each month
• Dysphagia (oropharyngeal, esophageal, functional, neuromuscular)
• History of recurrent aspiration episodes
• Proven Gastroparesis
• Allergy to the following generally regarded as safe ingredients (GRAS): glycerol, acid resistant hypromellose (HPMC), gellan gum, cocoa butter, titanium dioxide
• Adverse event attributable to previous FMT
• Allergy/intolerance to pump inhibitor therapy
• Any condition for which the investigator thinks the FMT treatment may pose a health risk (e.g. severely immunocompromised)
• Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
• During the trial period until one week after the trial end: Non-use of appropriate contraceptives in females of childbearing potential (e.g. condoms, intrauterine device (IUD), hormonal contraception, or other means considered adequate by the responsible investigator) or in males with a child-fathering potential (condoms, or other means considered adequate by the responsible investigator during treatment - Well-founded doubt about the patient's cooperation

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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