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Microbiome Modulation
Fecal Microbiota Transplant + Dietary Fiber for Graft-versus-Host Disease
Phase 1
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bacterial composition of stool
Genes, Bacterial
Incidence of adverse events
Secondary outcome measures
CR or partial response (PR) after the initial FMT
Complete response (CR) after the initial FMT
Decrease in stool volume
+5 moreTrial 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
Biospecimen Collection
2004
Completed Phase 2
~1730
Fecal Microbiota Transplantation
2016
Completed Phase 2
~350
Nutritional Supplementation
2019
Completed Early Phase 1
~220
Colonoscopy
2012
Completed Phase 3
~115560
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,834 Previous Clinical Trials
47,310,563 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,173 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,196 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
10 Patients Enrolled for Graft-versus-Host Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had a blockage in my intestines before.I have had a bowel perforation in the past.I have a history of inflammatory bowel disease.I have had diverticulitis in the past.I have a severe food allergy.I have had surgery to remove part of my intestines.I have had a gastric bypass surgery.I am not pregnant, planning a pregnancy, or breastfeeding, and if capable of bearing children, I have a negative pregnancy test.The study team thinks I can't safely join the study.I had a stem cell transplant from a donor within the last 100 days.I have been diagnosed with celiac disease through blood tests or a biopsy.I have mild to severe GI issues due to a recent transplant.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.My white blood cell count has been stable for three days after a transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (upper FMT)
- Group 2: Arm II (Lower FMT)
- Group 3: Arm III (upper FMT, fiber supplementation)
- Group 4: Arm IV (Lower FMT, fiber supplementation)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential hazards should a person be cognizant of upon undergoing Colonoscopy?
"Our assessment of the safety profile for colonoscopy is 1 on a scale of 1 to 3. This judgement is informed by this being an early stage trial with limited evidence supporting its efficacy and security."
Answered by AI
Has recruitment for this experiment commenced?
"As per the information accessible on clinicaltrials.gov, this trial is not accepting participants at present. It was posted on July 1st 2023 and modified for the last time November 1st 2022. Nevertheless, there are 169 other medical trials that currently require volunteers to join them in their pursuits of knowledge."
Answered by AI
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