Clinical trial NCT01501162: Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
Official title: Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholic Liver Disease
Keywords: hepatitis, alcohol
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2011-12-29
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Background/Aims: Alcoholic hepatitis (AH) is one of the leading causes of liver diseases. Gut-derived microbial lipopolysaccharide (LPS) has been known as a central role in the pathogenesis of AH. Some animal studies suggested an emerging role of probiotics in restoration of the bowel flora and improving liver enzymes. We explored the therapeutic effects of probiotics in patients with AH.

Methods: Between September 2010 and April 2012, we 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.

Eligibility criteria: Inclusion Criteria:

* Alcoholic Hepatitis

Exclusion Criteria:

* Cancer
* Viral Hepatitis, other Hepatitis

Primary outcomes:
measure: Liver Enzymes(ALT)
timeFrame: 7 days after probiotics
Secondary outcomes:
measure: Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines
timeFrame: 7 days after probiotics
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
Study officials:
affiliation: Department of Internal Medicine, Hallym University Chuncheon Sacred Heart Hospital
name: Ki Tae Suk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.