NCT05067595

Fecal Microbiota Transplant and Dietary Fiber Supplementation for the Treatment of Gut Graft Versus Host Disease

A Randomized, Controlled, Phase I Study of Fecal Microbiota Transplant and Dietary Fiber Supplementation in Graft Versus Host Disease

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies how well fecal microbiota transplant and dietary fiber supplementation work in treating patients with gut graft versus host disease. Fecal microbiota transplant entails inoculating donor stool into a recipient's gastrointestinal tract. Changing the gut microbiome by fecal microbiota transplant and fiber supplementation may help treat gut graft versus host disease.

Detailed description

OUTLINE: Patients are randomized to 1 of 4 arms. ARM I: Patients receive upper FMT capsules orally (PO) over 5 days or via post-pyloric or nasogastric (NG) feeding tube over 2 days. ARM II: Patients undergo lower FMT via colonoscopy on day 0. ARM III: Patients receive upper FMT capsules PO over 5 days or via post-pyloric or NG feeding tube over 2 days. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from the first day of FMT administration and up to 6 weeks post FMT. ARM IV: Patients undergo lower FMT via colonoscopy on day 0. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from day 0 up to 6 weeks post FMT. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study. After completion of study treatment, patients are followed up for 365 days.

Conditions

• Intestinal Graft Versus Host Disease

Interventions

Type	Name	Description
PROCEDURE	Colonoscopy	Undergo lower FMT via colonoscopy
BIOLOGICAL	Fecal Microbiota Transplantation	Given upper FMT PO or via post-pyloric or NG feeding tube
BIOLOGICAL	Fecal Microbiota Transplantation	Undergo lower FMT via colonoscopy
DIETARY_SUPPLEMENT	Nutritional Supplementation	Given dietary fiber supplementation PO or via post-pyloric or NG feeding tube
OTHER	Survey Administration	Ancillary studies
PROCEDURE	Biospecimen Collection	Undergo tissue, stool, stool swabs, and blood sample collection

Timeline

• Start date: 2025-01-24
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2021-10-05
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study