Role of VSL#3 in patients with nonalcoholic fatty liver disease

Small intestine bacterial overgrowth and role of probiotic, VSL#3 in patients with nonalcoholic fatty liver disease

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000074

Enrollment

Registered

2008-06-09

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients with Non alcoholic fatty liver disease

Interventions

Intervention1: VSL#3 capsules (112.5 billion per capsule): 2 caps t.i.d. for 1 year Control Intervention1: Placebo capsules: 2 capsules t.i.d. for 1 year (oral) Control Intervention2: Norfloxacin 200

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with raised liver enzymes (AST/ALT) at least 1.5 times the normal for more than three months 2. No history of alcohol intake or intake less than 20g/d (to be confirmed from at least two family members) 3. Negative viral markers (HBsAg and anti HCV) 4. Negative autoimmune markers (anti nuclear anti bodies (ANA), anti smooth muscle antibody (ASMA), anti liver kidney microsomal antibody (anti LKM), antimitochondrial antibody (AMA) 5. Normal ceruloplasmin 6. Negative KF ring 7. Normal iron studies 8. Liver biopsy consistent with features of NAFLD

Exclusion criteria

Exclusion criteria: 1. Pregnant females 2. Patients with diabetes mellitus 3. Patients with cirrhosis on imaging or liver biopsy 4. Patients with history of drug intake likely to cause NAFLD (e.g. corticosteroids, methotrexate, tamoxifen etc)

Design outcomes

Primary

Measure	Time frame
1. To study if small intestine bacterial overgrowth occurs in non diabetic patients with nonalcoholic fatty liver disease. 2. To study the role of probiotic VSL#3, antibiotic norfloxacin and placebo in achieving biochemical and histological response in patients with nonalcoholic fatty liver disease. Timepoint: 1 year treatment period	—

Secondary

Measure	Time frame
1. To study intestinal transit time in non diabetic patients with nonalcoholic fatty liver disease. 2. To study the role of various cytokines, adipokines and endotoxemia and their relation with insulin resistance in patients with nonalcoholic fatty liver disease. Timepoint: 1 year treatment period	—

Countries

India

Contacts

Public ContactDr S K Acharya

AIIMS

subratacharya2004@yahoo.com9868397200

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 20, 2026