NCT01922895

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 2, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

4.9 years

First QC Date

August 12, 2013

Results QC Date

January 9, 2022

Last Update Submit

February 4, 2022

Conditions

Acute Alcoholic Hepatitis

Keywords

Alcoholic HepatitisMELD < 20ProbioticNutritional SupplementLactobacillus Rhamnosus GG

Outcome Measures

Primary Outcomes (1)

  • MELD Score

    Change in MELD scoring system for assessing the severity of chronic liver disease; MELD (Model of End Stage Liver Disease) scoring system for assessing the severity of chronic liver disease; calculated from serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) MELD = 3.8\[Ln serum bilirubin (mg/dL)\] + 11.2\[Ln INR\] + 9.6\[Ln serum creatinine (mg/dL)\] + 6.4. MELD score range from 6-40 with higher scores indicating more severe liver disease and a worse outcome.

    30 days

Secondary Outcomes (2)

  • MELD Score

    180 days

  • MELD Score

    90 days

Study Arms (2)

Placebo for Probiotic

PLACEBO COMPARATOR

Placebo capsule that matches the probiotic capsule in appearance will be given once daily for 180 days.

Drug: Placebo for Probiotic

Lactobacillus Rhamnosus GG

ACTIVE COMPARATOR

Dietary supplement capsule (Lactobacillus Rhamnosus GG) will be given once daily for 180 days.

Dietary Supplement: Lactobacillus Rhamnosus GG

Interventions

Lactobacillus Rhamnosus GGDIETARY_SUPPLEMENT

Probiotic nutritional supplement; Lactobacillus Rhamnosus GG

Also known as: Culturelle
Lactobacillus Rhamnosus GG
Placebo for ProbioticDRUG

Capsule manufactured without active ingredients.

Also known as: Dummy capsule
Placebo for Probiotic

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to provide informed consent by subject or appropriate family member
  • Age between 21-70 years
  • Recent alcohol consumption \> 50 g/d for \> 6 months, continuing within two months before enrollment
  • At least 2 of the following symptoms or signs of acute alcoholic hepatitis: Anorexia, nausea, RUQ pain, jaundice, leukocytosis, hepatomegaly AND
  • Elevation of AST \> 80 U/L, but \< 500 U/L at the time of admission or within 3 days of baseline visit; AST \> ALT and ALT \< 200 U/L; total bilirubin \> 3 mg/dL AND
  • Model for End-Stage Liver Disease (MELD) \<20
  • Willingness to utilize two reliable forms of contraception (both males and females of childbearing potential) from screening through the first six weeks of study.

You may not qualify if:

  • Hypotension with BP \< 80/50 after volume repletion
  • Pregnancy; incarceration; inability to provide consent or lack of appropriate family member
  • Acute gastrointestinal bleeding requiring \> 2 units blood transfusion within the previous 4 days
  • Undue risk from immunosuppression: Positive HBsAg; a positive skin PPD skin test or history of treatment for tuberculosis; history of any malignancy including hepatocellular carcinoma; known HIV infection
  • Treatment with corticosteroids or other immunosuppressive medications including specific anti-TNF therapy (not including pentoxifylline), calcineurin inhibitors for \> 3 days within the previous 3 months.
  • Evidence of acute pancreatitis: CT evidence and/or amylase or lipase \> 5 X upper limit of normal
  • Serious cardiac, respiratory or neurologic disease or evidence of autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilsons disease, hemochromatosis, secondary iron overload due to chronic hemolysis, alpha-1-antitrypsin deficiency
  • Acute or chronic kidney injury with serum creatinine \> 3.0 mg/dl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

U Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (2)

  • Vatsalya V, Feng W, Kong M, Hu H, Szabo G, McCullough A, Dasarathy S, Nagy LE, Radaeva S, Barton B, Mitchell M, McClain CJ. The Beneficial Effects of Lactobacillus GG Therapy on Liver and Drinking Assessments in Patients with Moderate Alcohol-Associated Hepatitis. Am J Gastroenterol. 2023 Aug 1;118(8):1457-1460. doi: 10.14309/ajg.0000000000002283. Epub 2023 Apr 11.

    PMID: 37040544DERIVED

  • Vatsalya V, Cave MC, Kong M, Gobejishvili L, Falkner KC, Craycroft J, Mitchell M, Szabo G, McCullough A, Dasarathy S, Radaeva S, Barton B, McClain CJ. Keratin 18 Is a Diagnostic and Prognostic Factor for Acute Alcoholic Hepatitis. Clin Gastroenterol Hepatol. 2020 Aug;18(9):2046-2054. doi: 10.1016/j.cgh.2019.11.050. Epub 2019 Dec 4.

    PMID: 31811953DERIVED

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

HepatitisLiver DiseasesDigestive System DiseasesLiver Diseases, AlcoholicAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Mack C. Mitchell, MD
Organization
U.T. Southwestern Medical Center
mack.mitchell@utsouthwestern.edu
2146485036

Study Officials

  • Mack C Mitchell, M.D.

    U Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Vice-Chair Internal Medicine

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 14, 2013

Study Start

August 1, 2013

Primary Completion

July 1, 2018

Study Completion

August 31, 2021

Last Updated

March 2, 2022

Results First Posted

March 2, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)