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Fecal Microbiota Transplantation (FMT) in Nonalcoholic Steatohepatitis(NASH). A Pilot Study

NCT02469272 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2017-11-01

No results posted yet for this 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.

Conditions

  • Nonalcoholic Fatty Liver Disease

Interventions

DRUG

Fecal Microbiota Transplantation

Administration of frozen fecal materials into gastrointestinal tract

Sponsors & Collaborators

  • Lifespan

    lead OTHER

Principal Investigators

  • Kittichai Promrat, M.D. · Lifespan

  • Colleen Kelly, M.D. · Lifespan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02469272 on ClinicalTrials.gov