A Phase 2a, Randomized, Double-blinded, Placebo-controlled Study to evaluate Safety and Efficacy of Fecal Microbiota Transplantation Capsules administered with Standard-of-Care therapy for Prevention of Relapse in Adults with Ulcerative Colitis
- To prevent relapse in patients with Ulcerative Colitis (UC) in remission after administering fecal microbiota transplant (FMT) capsules plus Standard-Of-Care (SOC) treatment compared to placebo plus SOC treatment for 12 weeks.
- To evaluate the safety of FMT capsules given orally for 12 weeks in patients with UC in remission.
Major Inclusion criteria
- Adult ≥18 years of age
- History of active UC in the past 12 months.
- Remission of UC based on clinical grounds and on stable maintenance therapy, defined as stable dose of immunomodulator (azathioprine/imuran, 6-mercaptopurine/6-MP) for 3 months and other medications without change for 1 month.
Major Exclusion criteria:
- History of other active gastrointestinal conditions such as irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae/strictures, chronic parasitic infections, diverticulitis etc. or known history of bile acid diarrhea
- History of recurrent Clostridium difficile infection or FMT in the past 6-months
- Active HIV, Hepatitis B, or Hepatitis C infections.
- Compromised immune system or history of active cancer and/or ongoing chemotherapy
The purpose of this study is to see how well an investigational new drug containing FMT, works to reverse the abnormal gut microbiome in patients with UC as a way to prevent relapse and inflammation. The duration of the study is approximately 9 months (including 12 weeks of treatment and 6 months of safety follow up).
Description of Treatment (mechanism of action):
The FMT capsules contains intestinal microbes from three healthy stool donors carefully screened for infections and other known medical conditions, as per recommendations by the FDA. Participants will be randomized to receive one of the two capsules; FMT or placebo. Participants will have 2 out of 3 chances (67%) of receiving the FMT capsules. Total 8 doses will be given over 12 weeks and each dose consists of six capsules (60g).
Patient Participation Requirements:
The study involves 3 clinic visits and several follow-up phone calls. Participants will also be asked to provide their medical history, stool and blood samples, physical examination, and complete two short questionnaires related to quality of life and anxiety/depression.
Possible risks and side effects:
1. Possible side effects that may occur with FMT are usually mild, temporary and resolve without medical intervention. Known risks include mild intestinal conditions: excess gas, abdominal bloating, abdominal cramp/pain, mild diarrhea or constipation, changed bowel habits, and rarely nausea, vomiting, and a low-grade fever.
2. All donors and donor stools have been carefully screened for any known diseases, pathogens, and resistant factors that could be transferred through FMT. There is a very low risk that patient might receive a disease if the stool donor has an unreported disease that can be passed in stool.