CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 231 enrolled
Drug / intervention
VSL#3 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00973908
NCT00973908Phase 3Completed
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Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea

National Health Service, United Kingdom·interventional·Posted Sep 9, 2009·Updated Apr 26, 2013

In Brief

A Phase 3 clinical trial evaluating VSL#3 and Placebo for Diarrhoea. Completed, enrolled 231 participants across 5 sites.

Detailed Summary

The investigators aim to investigate whether the routine use of the probiotic formulation VSL#3 co-prescribed with antibiotics reduces the incidence of both Antibiotic associated diarrhoea and Clostridium Difficile associated diarrhoea.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhoea
CountriesUnited Kingdom
CollaboratorsWrightington, Wigan and Leigh NHS Foundation Trust, Ferring Pharmaceuticals, South London and Maudsley NHS Foundation Trust, North Bristol NHS Trust, Hull University Teaching Hospitals NHS Trust

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2009
Enrollment StartApr 1, 2010
Primary CompletionApr 1, 2012
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.8 years ago

Interventions

VSL#3drug

Patients will o receive one VSL #3 sachets twice a day for the duration of the antibiotic course and for one week after.

Placebodrug

Patients will one placebo sachet twice a day for the duration of the antibiotic course and for one week after.