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

NCT05067595 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

  • Intestinal Graft Versus Host Disease

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • David Fredricks · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-24
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05067595 on ClinicalTrials.gov