A Randomized, Controlled, Phase I Study of Fecal Microbiota Transplant and Dietary Fiber Supplementation in Graft Versus Host Disease
Fred Hutchinson Cancer Center
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.
Description
OUTLINE: Patients are randomized to 1 of 4 arms. ARM I: Patients receive upper FMT capsules orally (PO) over 5 days or via post-pyloric or nasogastric (NG) feeding tube over 2 days. ARM II: Patients undergo lower FMT via colonoscopy on day 0. ARM III: Patients receive upper FMT capsules PO over 5 days or via post-pyloric or NG feeding tube over 2 days. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from the first day of FMT administration and up to 6 weeks post FMT. ARM IV: Patients undergo lower FMT via colonoscopy on day 0. Patients also receive fib…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 18 years of age or older * History of allogeneic hematopoietic stem cell transplant in the past 365 days * Post-engraftment, defined by time period following three consecutive days of sustained neutrophil engraftment with an absolute neutrophil count of at least 500 cells/mm\^3 * Mild to severe acute GI GvHD, at least stage 1, as measured by one of the following: * Modified Glucksberg criteria for GI GvHD averaged over 3 consecutive days and without another explanation for diarrhea such as laxative use or infection. In patients who have already had GI biopsy, biopsy h…
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
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington