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Microbiome Modulation

Fecal Microbiota Transplant + Dietary Fiber for Graft-versus-Host Disease

Phase 1

Recruiting

Led By David Fredricks

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

History of allogeneic hematopoietic stem cell transplant in the past 100 days

Must not have

History of intestinal obstruction

History of bowel perforation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing how well a fecal microbiota transplant and dietary fiber supplementation work in treating patients with gut graft versus host disease.

Who is the study for?

This trial is for adults over 18 who had a stem cell transplant in the last 100 days and are now experiencing mild to severe gut graft versus host disease. They must not have a history of serious bowel issues or allergies to specific medications, and women must not be pregnant or breastfeeding.

What is being tested?

The study tests if fecal microbiota transplants (donor stool into the patient's gut) combined with dietary fiber can treat gut graft versus host disease after stem cell transplantation. It includes colonoscopies and surveys to monitor effects.

What are the potential side effects?

Potential side effects may include digestive discomfort, changes in bowel habits, allergic reactions, or infection due to the introduction of donor stool and increased fiber intake.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I had a stem cell transplant from a donor within the last 100 days.

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My white blood cell count has been stable for three days after a transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a blockage in my intestines before.

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I have had a bowel perforation in the past.

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I have a history of inflammatory bowel disease.

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I have had diverticulitis in the past.

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I have a severe food allergy.

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I have had surgery to remove part of my intestines.

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I have had a gastric bypass surgery.

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I am not pregnant, planning a pregnancy, or breastfeeding, and if capable of bearing children, I have a negative pregnancy test.

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I have been diagnosed with celiac disease through blood tests or a biopsy.

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I am willing and able to follow all study procedures including taking oral treatments, undergoing a colonoscopy, taking fiber supplements, providing stool samples, and completing surveys.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bacterial composition of stool

Genes, Bacterial

Incidence of adverse events

Secondary study objectives

CR or partial response (PR) after the initial FMT

Complete response (CR) after the initial FMT

Gut and overall GvHD grade

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm IV (Lower FMT, fiber supplementation)Experimental Treatment5 Interventions

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.

Group II: Arm III (upper FMT, fiber supplementation)Experimental Treatment4 Interventions

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.

Group III: Arm II (Lower FMT)Experimental Treatment4 Interventions

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

Group IV: Arm I (upper FMT)Experimental Treatment3 Interventions

Patients receive upper FMT capsules PO over 2 days. Patients also undergo tissue, stool, stool swabs, and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fecal Microbiota Transplantation

2020

Completed Phase 2

~440

Biospecimen Collection

2004

Completed Phase 3

~2020