NCT03006809

Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Najwa Elnachef · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective unblinded, randomized trial for the use of Fecal Microbiota Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or without antibiotic pretreatment.

Detailed description

This is a prospective open-label, randomized trial for the use of Fecal Microbiota Transplantation (FMT) for the treatment of Ulcerative Colitis (UC), in combination with or without antibiotic pretreatment. This trial involves 11 study visits at UCSF in San Francisco, CA. The routes of administration will be via colonoscopy for all subjects with maintenance therapy administered orally (i.e. using encapsulated FMT) for half of the subjects and per rectum by enema in the other half of the subjects. Additionally, the utility of pretreatment antibiotics will be assessed.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplantation (FMT), OpenBiome	Delivered by colonoscopy, enema or orally (as capsules)
OTHER	pretreatment antibiotics	5 day course (vancomycin PO 500mg bid, metronidazole PO 500mg bid, and neomycin PO 500mg bid) starting 6 days prior FMT

Timeline

• Start date: 2017-03-02
• Primary completion: 2020-05-04
• Completion: 2021-04-04
• First posted: 2016-12-30
• Last updated: 2021-04-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study