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Novel Therapies in Moderately Severe Acute Alcoholic Hepatitis

NCT01922895 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-03-02

Study results available
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Summary

This study is being done to find out whether a diet supplemented with a probiotic nutrient can improve alcoholic hepatitis and gut complications compared to routine standard care.

Conditions

  • Acute Alcoholic Hepatitis

Interventions

DIETARY_SUPPLEMENT

Lactobacillus Rhamnosus GG

Probiotic nutritional supplement; Lactobacillus Rhamnosus GG

DRUG

Placebo for Probiotic

Capsule manufactured without active ingredients.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • The Cleveland Clinic

    collaborator OTHER

  • University of Massachusetts, Worcester

    collaborator OTHER

  • University of Louisville

    collaborator OTHER

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Mack C Mitchell, M.D. · U Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-01
Primary Completion
2018-07-01
Completion
2021-08-31

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 NCT01922895 on ClinicalTrials.gov