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Microbiota Restoration

Fecal Microbiota Transplantation (FMT) for Gastrointestinal Disease

Phase 2
Waitlist Available
Led By Leland Metheny, MD
Research Sponsored by Leland Metheny
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months from start of treatment
Awards & highlights

Study Summary

This trial is for patients with GI-aGVHD that is steroid-refractory. You are being asked to take part in this study because you have recently been diagnosed with GI-GVHD. The standard of care for GI-aGVHD is steroids. When aGVHD does not respond to steroids it is described as steroid-refractory aGVHD. There is no standard therapy for steroid-refractory GI-aGVHD.

Eligible Conditions
  • Gastrointestinal Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months from start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months from start of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of FMT therapy in high risk and in steroid refractory GI-aGVHD as defined as number of responses at day 28 (+/- 3 days) post FMT treatment
Number of participants experiencing toxicity
Secondary outcome measures
Non-relapse mortality (NRM) as measured by percentage of participants who die not related to relapse
Overall survival (OS) as measured by percentage of participants who are alive at end of trial
Percentage of participants who develop cGVHD by the end of trial
+3 more

Side effects data

From 2016 Phase 1 trial • 23 Patients • NCT02108821
48%
Abdominal Pain
22%
Flatulence and bloating
22%
Diarrhea
13%
Emesis
9%
Bloody stools
9%
Nausea
4%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fecal Microbiota Transplantation

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota Transplantation (FMT)Experimental Treatment1 Intervention
One dose of FMT equal to 30 capsules will be administered on day 1 of a 28 day cycle. Steroids and routine GVHD prophylaxis medications and antibiotics may be administered concurrently with FMT therapy. Participants will be followed for 28 days following completion of the FMT dose or protocol defined outcome. aGVHD will be treated as per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation (FMT)
2016
Completed Phase 1
~170

Find a Location

Who is running the clinical trial?

Leland MethenyLead Sponsor
4 Previous Clinical Trials
70 Total Patients Enrolled
Leland Metheny, MDPrincipal InvestigatorCase Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
7 Previous Clinical Trials
146 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Fecal Microbiota Transplantation For The Treatment Of Gastro-Intestinal Acute GVHD
Leland Metheny 2022. "Fecal Microbiota Transplantation For The Treatment Of Gastro-Intestinal Acute GVHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04059757.
~0 spots leftby Apr 2025
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