Actively Recruiting
Fecal Microbiota Transplant and Dietary Fiber Supplementation for the Treatment of Gut Graft Versus Host Disease
Led by Fred Hutchinson Cancer Center · Updated on 2026-03-11
72
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Fecal Microbiota Transplant and Dietary Fiber Supplementation for the Treatment of Gut Graft Versus Host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- History of allogeneic hematopoietic stem cell transplant in the past 365 days
- Post-engraftment defined by three consecutive days with neutrophil count of at least 500 cells/mm^3
- Mild to severe acute gastrointestinal graft versus host disease at least stage 1 measured by Modified Glucksberg criteria or biopsy evidence
You will not qualify if you...
- History of serious adverse events related to fecal microbiota transplant
- History of bowel perforation, gastrointestinal resection, intestinal obstruction, or diverticulitis in the last 90 days
- History of celiac disease confirmed by testing or biopsy
- History of severe dietary allergy grade 2 or higher
- Cytomegalovirus (CMV) seronegative unless donor is also CMV seronegative with negative PCR
- Allergies to ingredients in FMT or related substances
- Currently pregnant, planning pregnancy, or breastfeeding
- Not willing to use effective birth control if able to conceive
- Unable or unwilling to participate in study procedures
- Investigator opinion that participation is unsafe or unreasonable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
D
David Fredricks
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here