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RECRUITING
NCT05067595
PHASE1

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

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2025-01-24

Completion Date

2027-12-31

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

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

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States