Poop pills and fiber: new hope for bone marrow transplant complications?
NCT ID NCT05067595
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time
Summary
This early-stage study tests whether giving patients a fecal transplant (donated stool) along with extra dietary fiber can help treat gut graft versus host disease, a serious complication after a stem cell transplant. About 72 adults who had a stem cell transplant in the past year and have gut GvHD will take part. The goal is to see if changing the gut bacteria can ease symptoms and is safe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2025
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 histology must be compatible with GVHD, although biopsy is not required * Biopsy evidence of GI GVHD in the upper or lower GI tract Exclusion Criteria: * History of previous serious adverse events associated with FMT * History of bowel perforation in the last 90 days * History of gastrointestinal resection in the last 90 days * History of small bowel obstruction without surgical intervention in the last 30 days, or 90 days with surgery, or history of large bowel obstruction in last 90 days * History of diverticulitis in the last 60 days * History of celiac disease confirmed by serologic testing or small bowel biopsy * History of severe dietary allergy as designated by World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System grade 2 or more * Subjects who are cytomegalovirus (CMV) seronegative at the time of enrollment as indicated by clinical testing unless the fecal microbiota transplant (FMT) donor is CMV seronegative with negative plasma polymerase chain reaction (PCR) assays for CMV. * Known allergies to loperamide, sodium chloride, glycerol, theobroma oil, hide bovine gelatin, sodium lauryl sulfate, colorants FD\&C, titanium dioxide, polyethylene glycol, sodium sulfate, sodium bicarbonate, sodium phosphate, benzalkonium chloride, disodium EDTA or potassium chloride. * Currently pregnant, planning to become pregnant or breastfeeding during the study period. Women of childbearing potential (those who are not post-menopausal or post-hysterectomy) must be negative for pregnancy per urine pregnancy test at enrollment * Individuals with the ability to conceive children who are not willing to abstain from sexual activity or use an effective form of birth control during the duration of the study * Unwilling or unable to participate in study procedures including oral intake of FMT, colonoscopy, fiber supplementation, collection of stool samples and completion study surveys * Cannot reasonably and safely participate in the study in the opinion of the investigators
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute gastrointestinal graft-versus-host disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Fred Hutch/University of Washington Cancer Consortium
RECRUITINGSeattle, Washington, 98109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a cell injection calm the gut after a stem cell transplant?
- Poop pills could save lives after stem cell transplants
- Poop pills? no, a colonoscopy with donor stool to fight a deadly transplant complication
- Could vitamin c help protect the gut in transplant patients?
- Withdrawn trial sought to protect gut cells in GVHD patients