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

Conditions

• Intestinal Graft Versus Host Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Colonoscopy — PROCEDURE
  Undergo lower FMT via colonoscopy
• Fecal Microbiota Transplantation — BIOLOGICAL
  Given upper FMT PO or via post-pyloric or NG feeding tube
• Fecal Microbiota Transplantation — BIOLOGICAL
  Undergo lower FMT via colonoscopy
• Nutritional Supplementation — DIETARY_SUPPLEMENT
  Given dietary fiber supplementation PO or via post-pyloric or NG feeding tube
• Survey Administration — OTHER
  Ancillary studies
• Biospecimen Collection — PROCEDURE
  Undergo tissue, stool, stool swabs, and blood sample collection

Study Details

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.

Key Dates

Start date

Jan 24, 2025

Status verified

Mar 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

72 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

Bacterial composition of stool [ Time Frame: At baseline ]

Central Contacts

• David Fredricks
  206.667.1935
  [email protected]

Locations (1)

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