NCT01501162

Brief Summary

Background/Aims: The investigators explored the therapeutic effects of probiotics in patients with AH. Methods: Between September 2010 and April 2012, the investigators conducted a 7-day, double-controlled, randomized, prospective clinical trial comparing the efficacy of probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines. AH was defined as an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 and elevated AST (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of probiotics (1500 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines were checked at baseline and again after therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 29, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

January 27, 2015

Completed
Last Updated

April 14, 2015

Status Verified

December 1, 2014

Enrollment Period

1.9 years

First QC Date

December 27, 2011

Results QC Date

December 31, 2014

Last Update Submit

March 24, 2015

Conditions

Alcoholic Liver Disease

Keywords

hepatitis, alcohol

Outcome Measures

Primary Outcomes (1)

  • Liver Enzymes(ALT)

    Blood analysis was performed using standard methodologies.

    7 days after probiotics

Secondary Outcomes (1)

  • Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines

    7 days after probiotics

Study Arms (2)

alcohol, hepatitis, Placebo

PLACEBO COMPARATOR

We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis

Drug: alcohol, hepatitis, Placebo

hepatitis, alcohol, probiotics

ACTIVE COMPARATOR

We explored the therapeutic effects of probiotics in patients with alcoholic hepatitis

Drug: hepatitis, alcohol, probiotics

Interventions

hepatitis, alcohol, probioticsDRUG

7 days of probiotics (1500 mg/day)

Also known as: LACTOWELL
hepatitis, alcohol, probiotics
alcohol, hepatitis, PlaceboDRUG

Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.

Also known as: Placebo
alcohol, hepatitis, Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Alcoholic Hepatitis

You may not qualify if:

  • Cancer
  • Viral Hepatitis, other Hepatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

Chuncheon, 200-704, South Korea

Location

Related Publications (1)

  • Han SH, Suk KT, Kim DJ, Kim MY, Baik SK, Kim YD, Cheon GJ, Choi DH, Ham YL, Shin DH, Kim EJ. Effects of probiotics (cultured Lactobacillus subtilis/Streptococcus faecium) in the treatment of alcoholic hepatitis: randomized-controlled multicenter study. Eur J Gastroenterol Hepatol. 2015 Nov;27(11):1300-6. doi: 10.1097/MEG.0000000000000458.

    PMID: 26302024DERIVED

MeSH Terms

Conditions

Liver Diseases, AlcoholicHepatitis, Alcoholic

Interventions

Hepatitis A VaccinesEthanolProbiotics

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersHepatitis

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex MixturesAlcoholsOrganic ChemicalsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Dr. Ki Tae Suk
Organization
Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea
ktsuk@hallym.ac.kr
+82-33-240-5826

Study Officials

  • Ki Tae Suk, PhD

    Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor, assistant professor

Study Record Dates

First Submitted

December 27, 2011

First Posted

December 29, 2011

Study Start

October 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

April 14, 2015

Results First Posted

January 27, 2015

Record last verified: 2014-12

Locations

KR(1)