Fecal Microbiota Transplant and Dietary Fiber Supplementation for the Treatment of Gut Graft Versus Host Disease

NCT05067595 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: RG1006202NCI-2019-07698102761R01HL166107
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Bacterial composition of stool

  Analyses will consist of summary statistics of the bacterial diversity in the microbiome (e.g., the alpha diversity, the abundance of bacterial species associated with protection from graft versus host disease \[GvHD\]).

  At baseline

• Bacterial genes in stool

  Specifically abundance of genes related to fiber fermentation and short chain fatty acids production metabolites in stool, specifically short chain fatty acids will be assessed.

  At baseline

• Incidence of adverse events

  Will by assessed by computing the total number of adverse events (AE)s and serious adverse events (SAE)s, the number per patient, and the number of patients with at least one event. The type of AE/SAE and whether the AE/SAE is related to the fecal microbiota transplant (FMT) or not will be tabulated. These summaries will be computed overall as well as by randomization arm and stratification factor (steroid-responsive, versus steroid-dependent or -refractory disease status). The odds will be compared of at least one SAE per patient by randomization arm and stratification factor using logistic regression with independent variables for route of FMT administration, fiber supplementation, and steroid-responsive, versus steroid-dependent or -refractory disease status. Interaction terms will be considered between these factors and may use exact or firth logistic regression in the event that some categories have zero patients with a SAE.

  Up to 3 years

Secondary Outcomes (8)

• Complete response (CR) after the initial FMT

  At day 28

• CR or partial response (PR) after the initial FMT

  At day 28

• Gut and overall GvHD grade

  Up to 6 months

• Six-month survival

  At 6 months

• Quality of life

  Up to 3 years

Study Arms (4)

Arm I (upper FMT)

EXPERIMENTAL

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.

Biological: Fecal Microbiota Transplantation; Other: Survey Administration; Procedure: Biospecimen Collection

Arm II (Lower FMT)

EXPERIMENTAL

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

Procedure: Colonoscopy; Biological: Fecal Microbiota Transplantation; Other: Survey Administration; Procedure: Biospecimen Collection

Arm III (upper FMT, fiber supplementation)

EXPERIMENTAL

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.

Biological: Fecal Microbiota Transplantation; Dietary Supplement: Nutritional Supplementation; Other: Survey Administration; Procedure: Biospecimen Collection

Arm IV (Lower FMT, fiber supplementation)

EXPERIMENTAL

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.

Procedure: Colonoscopy; Biological: Fecal Microbiota Transplantation; Dietary Supplement: Nutritional Supplementation; Other: Survey Administration; Procedure: Biospecimen Collection

Interventions

Colonoscopy PROCEDURE

Undergo lower FMT via colonoscopy

Arm II (Lower FMT); Arm IV (Lower FMT, fiber supplementation)

Fecal Microbiota Transplantation BIOLOGICAL

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

Also known as: Fecal Material Transplantation, Fecal Transplantation, FMT, Poo Transplant, Poop Transplant, Stool Transplant

Arm I (upper FMT); Arm III (upper FMT, fiber supplementation)

Nutritional Supplementation DIETARY_SUPPLEMENT

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

Also known as: Supplementation

Arm III (upper FMT, fiber supplementation); Arm IV (Lower FMT, fiber supplementation)

Survey Administration OTHER

Ancillary studies

Arm I (upper FMT); Arm II (Lower FMT); Arm III (upper FMT, fiber supplementation); Arm IV (Lower FMT, fiber supplementation)

Biospecimen Collection PROCEDURE

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

Also known as: Biological Sample Collection

Arm I (upper FMT); Arm II (Lower FMT); Arm III (upper FMT, fiber supplementation); Arm IV (Lower FMT, fiber supplementation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Interventions

Colonoscopy; Fecal Microbiota Transplantation; Dietary Supplements

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Biological Therapy; Therapeutics; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David Fredricks

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Fredricks

CONTACT

206.667.1935; dfredric@fredhutch.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: October 5, 2021
• Study Start: January 24, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)