Recruiting
Phase 1

Fecal Microbiota Transplant & Dietary Fiber

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT05067595

Conditions

Intestinal Graft Versus Host Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Colonoscopy

Fecal Microbiota Transplantation

Fecal Microbiota Transplantation

Nutritional Supplementation

Survey Administration

Study Details

Brief 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.

Conditions

Intestinal Graft Versus Host Disease

Study ID

NCT05067595

Start date

Jan 24, 2025

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 intestinal obstruction in the last 90 days
  • History of diverticulitis in the last 90 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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (upper FMT)

Patients receive upper FMT capsules PO over 5 days or via post-pyloric or NG feeding tube over 2 days. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.

experimental: Arm II (Lower FMT)

Patients undergo lower FMT via colonoscopy on day 0. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.

experimental: Arm III (upper FMT, fiber supplementation)

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. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.

experimental: Arm IV (Lower FMT, fiber supplementation)

Patients undergo lower FMT via colonoscopy on day 0. Patients also receive fiber supplementation PO or via post-pyloric or NG feeding tube from day 0 up to 6 weeks post FMT. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.

Interventions

Colonoscopy

Undergo lower FMT via colonoscopy

Fecal Microbiota Transplantation

Given upper FMT PO or via post-pyloric or NG feeding tube

Fecal Microbiota Transplantation

Undergo lower FMT via colonoscopy

Nutritional Supplementation

Given dietary fiber supplementation PO or via post-pyloric or NG feeding tube

Survey Administration

Ancillary studies

Biospecimen Collection

Undergo tissue, stool, stool swabs, and blood sample collection

Primary outcome measure

  • Bacterial composition of stool [ Time Frame: At baseline ]
  • Bacterial genes in stool [ Time Frame: At baseline ]
  • Incidence of adverse events [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

David Fredricks

206.667.1935dfredric@fredhutch.org

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

David Fredricks

206-667-1935dfredric@fredhutch.org

Principal Investigator:

David Fredricks

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-03-11.