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

Purpose

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.

Condition

Intestinal Graft Versus Host Disease

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion 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

Exclusion Criteria

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

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Arm I (upper FMT)	Patients receive upper FMT capsules PO over 2 days. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.	Biological: Fecal Microbiota Transplantation Given upper FMT PO Other names: Fecal Material Transplantation Fecal Transplantation FMT Poo Transplant Poop Transplant Stool Transplant Other: Survey Administration Ancillary studies Procedure: Biospecimen Collection Undergo tissue, stool, stool swabs, and blood sample collection Other names: Biological Sample Collection
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.	Procedure: Colonoscopy Undergo lower FMT via colonoscopy Biological: Fecal Microbiota Transplantation Undergo lower FMT via colonoscopy Other names: Fecal Material Transplantation Fecal Transplantation FMT Poo Transplant Poop Transplant Stool Transplant Other: Survey Administration Ancillary studies Procedure: Biospecimen Collection Undergo tissue, stool, stool swabs, and blood sample collection Other names: Biological Sample Collection
Experimental Arm III (upper FMT, fiber supplementation)	Patients receive upper FMT capsules PO over 2 days. Patients receive fiber supplementation PO while on study. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.	Biological: Fecal Microbiota Transplantation Given upper FMT PO Other names: Fecal Material Transplantation Fecal Transplantation FMT Poo Transplant Poop Transplant Stool Transplant Dietary Supplement: Nutritional Supplementation Given dietary fiber supplementation PO Other names: Supplementation Other: Survey Administration Ancillary studies Procedure: Biospecimen Collection Undergo tissue, stool, stool swabs, and blood sample collection Other names: Biological Sample Collection
Experimental Arm IV (Lower FMT, fiber supplementation)	Patients undergo lower FMT via colonoscopy on day 0. Patients receive fiber supplementation PO while on study. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.	Procedure: Colonoscopy Undergo lower FMT via colonoscopy Biological: Fecal Microbiota Transplantation Undergo lower FMT via colonoscopy Other names: Fecal Material Transplantation Fecal Transplantation FMT Poo Transplant Poop Transplant Stool Transplant Dietary Supplement: Nutritional Supplementation Given dietary fiber supplementation PO Other names: Supplementation Other: Survey Administration Ancillary studies Procedure: Biospecimen Collection Undergo tissue, stool, stool swabs, and blood sample collection Other names: Biological Sample Collection

Recruiting Locations

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington 98109

Contact:
David Fredricks
206-667-1935
dfredric@fredhutch.org

More Details

NCT ID: NCT05067595
Status: Recruiting
Sponsor: Fred Hutchinson Cancer Center

Study Contact

David Fredricks
206.667.1935
dfredric@fredhutch.org

Detailed Description

OUTLINE: Patients are randomized to 1 of 4 arms. ARM I: Patients receive upper FMT capsules orally (PO) over 2 days. ARM II: Patients undergo lower FMT via colonoscopy on day 0. ARM III: Patients receive upper FMT capsules PO over 2 days. Patients receive fiber supplementation PO while on study. ARM IV: Patients undergo lower FMT via colonoscopy on day 0. Patients receive fiber supplementation PO while on study. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study. After completion of study treatment, patients are followed up for 365 days.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.