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Clinical Trial 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.


Clinical Trial Description

OUTLINE: Patients are randomized to 1 of 4 arms. ARM I: Patients receive upper FMT capsules orally (PO) over 2 days. ARM II: Patients undergo lower FMT via colonoscopy on day 0. ARM III: Patients receive upper FMT capsules PO over 2 days. Patients receive fiber supplementation PO while on study. ARM IV: Patients undergo lower FMT via colonoscopy on day 0. Patients receive fiber supplementation PO while on study. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05067595
Study type Interventional
Source Fred Hutchinson Cancer Center
Contact David Fredricks
Phone 206.667.1935
Email dfredric@fredhutch.org
Status Not yet recruiting
Phase Phase 1
Start date June 20, 2024
Completion date December 31, 2026

See also
  Status Clinical Trial Phase
Withdrawn NCT02425813 - Methylprednisolone Sodium Succinate in Treating Patients With Acute Graft-versus-Host Disease of the Gastrointestinal Tract Phase 2