Fred Hutchinson Cancer Center
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.
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…
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…
Undergo lower FMT via colonoscopy
Given upper FMT PO or via post-pyloric or NG feeding tube
Undergo lower FMT via colonoscopy
Given dietary fiber supplementation PO or via post-pyloric or NG feeding tube
Ancillary studies
Undergo tissue, stool, stool swabs, and blood sample collection
Arctuva estimate
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