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Microbiota Therapy
Fecal Microbiota Transplantation for Non-alcoholic Fatty Liver Disease
Phase 1
Waitlist Available
Led By Colleen Kelly, M.D.
Research Sponsored by Lifespan
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 12 weeks
Awards & highlights
Study Summary
Nonalcoholic steatohepatitis (NASH) is common, may progress to cirrhosis and is predicted to become a leading indication for liver transplantation in the near future. Though often associated with obesity and the metabolic syndrome, our current understanding of disease development is limited and there are few therapeutic options. Imbalance of gut bacteria is suspected to play a key role driving the progression of fatty liver disease and there is hope manipulation of these bacteria may be beneficial. This study will determine if fecal microbiota transplantation, using stool from lean donors, is an effective and safe treatment for NASH.
Eligible Conditions
- Non-alcoholic Fatty Liver Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
degree of hepatic steatosis as determined by MRI
Secondary outcome measures
Liver Function Tests
Markers of insulin sensitivity
Side effects data
From 2020 Phase 1 & 2 trial • 50 Patients • NCT0310684444%
Diarrhea
26%
Abdominal Pain
16%
Rectal Bleeding
12%
Constiption
10%
Fever
10%
Nausea
6%
Vomiting
6%
Fatigue
4%
Heart Burn
4%
Chills
4%
Migraine
4%
Yeast Infection
2%
Anemia
2%
IBD Flare
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota TransplantationExperimental Treatment1 Intervention
Intervention: standardized preparation of frozen fecal material from lean healthy donors Route: infused into the duodenum through the working channel of the instrument at upper endoscopy Dosing: 1 dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation
2016
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
LifespanLead Sponsor
40 Previous Clinical Trials
41,083 Total Patients Enrolled
Colleen Kelly, M.D.Principal InvestigatorLifespan
Kittichai Promrat, M.D.Principal InvestigatorLifespan
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
30 Patients Enrolled for Non-alcoholic Fatty Liver Disease
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