FMT for Crohn's Disease

Palo Alto (17 mi)

Overseen byByron Vaughn, MD, MS

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Minnesota

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests if taking healthy bacteria from donor stool by capsules or colonoscopy can help people with Crohn's disease who have had surgery. The goal is to see if this can prevent the disease from coming back by balancing their gut bacteria.

Eligibility Criteria

This trial is for adults over 18 with Crohn's Disease who've had ileocecal resection surgery. They must have been diagnosed at least 6 months ago, speak English, and be on stable medications for a month. Women should use birth control or abstain from sex. Participants can't join if they're pregnant, have certain polyps or colectomies, used probiotics or antibiotics recently, expect surgeries during the study, have very low neutrophil counts, severe food allergies, short life expectancy or advanced liver disease.

Treatment Details

The trial tests whether fecal microbiota transplant (FMT) via capsules has similar effects in increasing beneficial gut bacteria as FMT delivered through colonoscopy in post-surgery Crohn's patients. Participants will randomly receive either capsule FMT (cap-FMT) or colonoscopic FMT (colo-FMT), and their gut bacteria will be assessed through biopsies taken during a follow-up colonoscopy after eight weeks.

2Treatment groups

Experimental Treatment

Active Control

Group I: Capsule fecal microbiota material (cap-FMT)Experimental Treatment1 Intervention

Participants will receive colonoscopy at day 0 and week 8 and receive cap-FMT orally for five days post-colonoscopy. Stool swabs and samples will be collected regularly.

Group II: Colonoscopic fecal microbiota material (colo-FMT) plus placeboActive Control1 Intervention

Participants will receive colonoscopy at day 0 and week 8 and receive a placebo orally for five days post-colonoscopy. During the first colonoscopy, colo-FMT will be administered. Stool swabs and samples will be collected regularly.