Clinical Trial Goal
To find out if different methods of FMT, with or without fiber supplementation, is safe and works well to treat gut GVHD
You may be able to join this trial if you:
- Are 18 years old or older
- Have mild to severe GVHD of the gut
- Have had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last year
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
FMT is a procedure introducing healthy donor stool in pill form to a patient's gastrointestinal (GI) tract. Doctors think it can help treat GVHD of the gut by changing the gut microbiome.
In this trial, you’ll be randomized to 1 of 4 groups. Once you’re randomized, you’ll be told what group you’re in:
In this trial, you’ll be randomized to 1 of 4 groups. Once you’re randomized, you’ll be told what group you’re in:
- Group 1 – FMT of the upper GI tract
- Group 2 – FMT of the lower GI tract
- Group 3 - FMT of the upper GI tract plus fiber supplementation
- Group 4 - FMT of the lower GI tract plus fiber supplementation
Randomized means doctors will use a computer to assign you to a group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
You’ll get:
- Fiber supplementation - Group 3 and 4 only - A pill that you take by mouth or through a feeding tube 1 time each day for up to 1.5 months
- FMT of the upper GI tract - Group 1 and 3 only – A pill that you take by mouth or through a feeding tube 1 time each day for up to 5 days
- FMT of the lower GI tract - Group 2 and 4 only – Given using colonoscopy 1 time
You'll have biopsies and stool samples collected to see how well the treatment is working. The clinical trial doctors will check your health for 1 year.
The Food and Drug Administration (FDA) has approved FMT for the treatment of other diagnoses. Using it to treat GVHD is new and unproven.
Locations
Fred Hutch/University of Washington Cancer ConsortiumRECRUITING
Seattle, Washington
David Fredricks, 206-667-1935, dfredric@fredhutch.org
Sponsors
collaborator: National Heart, Lung, and Blood Institute (NHLBI), lead: Fred Hutchinson Cancer Center
