Safety and Efficacy of Fecal Microbiome Transplantation (FMT) in the Treatment of Antibiotic Dependent Pouchitis (ADP)
Pouchitis
About this trial
This is an interventional treatment trial for Pouchitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- University of North Carolina
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Active FMT, then open label FMT
Placebo FMT, then open label FMT
Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.