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Poop pills and fiber: new hope for bone marrow transplant complications?

NCT ID NCT05067595

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

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

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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

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Fred Hutch/University of Washington Cancer Consortium

    RECRUITING

    Seattle, Washington, 98109, United States

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