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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 undergo lower FMT via colonoscopy on day 0. Patients also receive fiber supplementation PO daily on days 1-42. ARM II: Patients undergo lower FMT via colonoscopy on day 0. ARM III: Patients receive upper FMT capsules PO over 2 days. Patients also receive fiber supplementation PO daily on days 0-41. ARM IV: Patients receive upper FMT capsules PO over 2 days. After completion of study treatment, patients are followed up for 180 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05067595
Study type Interventional
Source Fred Hutchinson Cancer Research Center
Contact David Fredricks
Phone 206.667.1935
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date March 1, 2022
Completion date October 1, 2022

See also
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