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VSL#3 and Spontaneous Bacterial Peritonitis

NCT01701297 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-10-28

No results posted yet for this study

Summary

Research question: Do oral probiotics in patients with cirrhosis and ascites reduce intestinal bacterial concentrations, ascitic bacterial DNA, SBP and bacteraemia compared to antibiotics or placebo?

This study is designed to investigate the effects of an oral probiotic (VSL#3; a mixture of "healthy" bacteria for the intestines) compared to an antibiotic or placebo in preventing infection developing in the abdominal fluid ("ascites") that collects in patients with advanced liver disease ("cirrhosis"). Patients already having had infection will be excluded from the study. Clear inclusion and exclusion criteria will be met and patients will be monitored throughout the study to examine whether they have required more hospitalisations, their rate infection in abdominal fluid or elsewhere and the level of liver function.

Conditions

  • Decompensated Cirrhosis
  • Ascites

Interventions

DRUG

cotrimoxazole

Cotrimoxazole 960mg orally each day (two 480mg tablets)

DRUG

VSL#3 active

The prescribed dose was 2 sachets (containing 900 billion bacteria) orally each day for 48 weeks

DRUG

VSL#3 placebo

This was two placebo sachets identical to VSL#3 active sachet. The prescribed dose was 2 sachets orally each day for 48 weeks

Sponsors & Collaborators

  • VSL Pharmaceuticals

    collaborator INDUSTRY

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Martin W James, BM BS FRCP PhD · NUH NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United Kingdom

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 NCT01701297 on ClinicalTrials.gov