FMT for Postop Crohn's Disease

Fecal Microbiota Transplant for Postoperative Crohn's Disease

People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery.

This study aims to determine if fecal microbiota transplant (FMT) taken by capsules results in the same amount of good bacteria in the guts as FMT by colonoscopy in people with Crohn's disease who have had surgery.

Participants will be randomized to get FMT by capsules or colonoscopy. Colonoscopy with biopsies 8-weeks after the FMT will be used to assess the good bacteria in the gut.

Study Overview

• Status: Active, not recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Biological: Capsule fecal microbiota material (cap-FMT); Biological: Colonoscopic fecal microbiota material (colo-FMT)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sharon Lopez; Phone Number: 612-625-8999; Email: skunkel@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able and willing to sign informed consent form
• Age 18 or older
• English speaking
• Established CD for at least 6-months based on typical clinical, endoscopic, and histopathic evidence.
• Prior ileocecal resection for CD
• Stable medications for 30 days
• Women of reproductive age: Agree to remain abstinent or use effective birth control
• Able and willing to comply with all study procedures

Exclusion Criteria:

• Antibiotic therapy within 15 days
• Probiotic therapy within 15 days
• Adenomatous polyps that have not been removed
• Anticipated antibiotic use over the study period
• Subtotal or total colectomy
• Current ostomy (ileostomy or colonoscopy)
• Anticipated surgical procedure over study period
• Pregnancy
• Severe food allergy
• Diagnosis of end stage liver disease or cirrhosis
• Absolute neutrophil count < 500 cell / uL
• Life expectancy < 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Capsule fecal microbiota material (cap-FMT); 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.	Biological: Capsule fecal microbiota material (cap-FMT); Cap-FMT consists of Lyophilized FMT administered at 5 x 10^11 bacteria per capsule daily for five days, for a total dose of 2.5 x 10^12 bacteria.
Active Comparator: Colonoscopic fecal microbiota material (colo-FMT) plus placebo; 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.	Biological: Colonoscopic fecal microbiota material (colo-FMT); Colo-FMT consists of rehydrated Lyophilized FMT material administered as a single dose of 2.5 x 10^12 bacteria as liquid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ileal-associated microbiota engraftment	Microbiota community of the ileum as sampled by ileal biopsies from colonoscopy. We will use SourceTracker, a Bayesian community-wide software, to assess composition and donor similarity.	8 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Byron Vaughn, MD, MS, University of Minnesota Department of Medicine / Gastroenterology, Hepatology, Nutrition

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): December 25, 2023
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Crohn's disease; Ileocecal resection; Fecal microbiota transplant; Intestinal microbiota transplant
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: GI-2022-30546

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No