RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized, Controlled, Phase I Study of Fecal Microbiota Transplant and Dietary Fiber Supplementation in Graft Versus Host Disease

Quick Facts

Study Start:2024-12-26

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05067595

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 18 years of age or older * History of allogeneic hematopoietic stem cell transplant in the past 100 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\^1 * Mild to severe acute GI GvHD stage 1 as measured by the modified Glucksberg criteria and averaged over 3 consecutive days in the last week. In patients who have already had GI biopsy, biopsy histology must be compatible with GVHD, although biopsy is not required	* History of previous serious adverse events associated with FMT * History of bowel perforation * History of bowel resection * History of intestinal obstruction * History of gastric bypass * History of diverticulitis * History of inflammatory bowel disease (i.e. Crohn's disease and ulcerative colitis) * 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 * Current evidence of mechanical obstruction of the bowel * 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

Inclusion Criteria

Exclusion Criteria

* 18 years of age or older
* History of allogeneic hematopoietic stem cell transplant in the past 100 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\^1
* Mild to severe acute GI GvHD stage 1 as measured by the modified Glucksberg criteria and averaged over 3 consecutive days in the last week. In patients who have already had GI biopsy, biopsy histology must be compatible with GVHD, although biopsy is not required

* History of previous serious adverse events associated with FMT
* History of bowel perforation
* History of bowel resection
* History of intestinal obstruction
* History of gastric bypass
* History of diverticulitis
* History of inflammatory bowel disease (i.e. Crohn's disease and ulcerative colitis)
* 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
* Current evidence of mechanical obstruction of the bowel
* 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

Contacts and Locations

Study Contact

David Fredricks

CONTACT

206.667.1935

dfredric@fredhutch.org

Principal Investigator

David Fredricks

PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Study Locations (Sites)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Fred Hutchinson Cancer Center

David Fredricks, PRINCIPAL_INVESTIGATOR, Fred Hutch/University of Washington Cancer Consortium

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-26

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-12-26

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Intestinal Graft Versus Host Disease