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Secondary Prophylaxis of Hepatic Encephalopathy With a Probiotic Preparation

NCT01110447 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2013-12-30

No results posted yet for this study

Summary

The aim of the proposed project is to study the effects of a probiotic preparation (VSL#3®) for the prevention of recurrence of HE (Hepatic encephalopathy) in patients after the recovery of an episode of overt HE (secondary prophylaxis)

Conditions

  • Hepatic Encephalopathy

Interventions

DRUG

VSL#3

VSL#3® is made up of 4 strains of Lactobacilli (L. paracasei, L. plantarum, L. acidophilus and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacteria (B. longum, B. infantis, B. breve) and 1 strain of Streptococcus thermophilus. Dose would be 1 sachet per day (Each sachet containing 900 Billion CFU). The duration of treatment would be for 24 weeks

OTHER

Placebo

Placebo sachets contain corn starch. Dose: 1 sachet per day Duration of treatment: 24 weeks

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    collaborator OTHER

  • CD Pharma India Pvt. Ltd.

    lead INDUSTRY

Principal Investigators

  • Radha K Dhiman, MD,DM,MNAMS · Postgraduate Institute of Medical Education & Research (PGIMER)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • India

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 NCT01110447 on ClinicalTrials.gov