RecruitingPhase 1NCT05067595

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

Sponsor

Fred Hutchinson Cancer Center

Enrollment

72 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

Intestinal Graft Versus Host Disease

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, a procedure called Colonoscopy, and others for people with intestinal graft versus host disease. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREColonoscopy

Undergo lower FMT via colonoscopy

BIOLOGICALFecal Microbiota Transplantation

Given upper FMT PO or via post-pyloric or NG feeding tube

BIOLOGICALFecal Microbiota Transplantation

Undergo lower FMT via colonoscopy

DIETARY_SUPPLEMENTNutritional Supplementation

Given dietary fiber supplementation PO or via post-pyloric or NG feeding tube

OTHERSurvey Administration

Ancillary studies

PROCEDUREBiospecimen Collection

Undergo tissue, stool, stool swabs, and blood sample collection

Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT05067595