Safety Evaluation of Fecal Microbiota Transplantation in Severe Alcoholic Hepatitis

Recruiting Phase 1 Phase 2 Interventional Study
Alcoholic Hepatitis
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Other
Participants needed
50 (estimated)
Sponsor
Prasun Kumar Jalal · Other
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About This Trial
This is a single center, randomized, parallel assignment, and double-blind placebo-controlled pilot study to characterize the intestinal microbiome in patients with severe Alcoholic Hepatitis (SAH) and evaluate the safety and the trends in improvement of diversity of intestinal microbiome following administration of lyophilized capsules containing microbiota suspension from well screened health do…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Any gender; male or female; aged 18- 75 years old. 2. Severe alcoholic hepatitis defined as 2.1 Onset of jaundice within prior 8 weeks. 2.2 Ongoing alcohol consumption of \>40 g/day (3 drinks) in females or \>60 g/day (4 drinks) in males for 6 months or more, with less than 6…
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