CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 81 enrolled
Drug / intervention
Lactobacillus plantarum 299v +3 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/NCT01886781
NCT01886781Phase 4Completed
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Randomised Controlled Trial: Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome

University of Stellenbosch·interventional·Posted Jun 26, 2013·Updated Sep 29, 2014

In Brief

A Phase 4 clinical trial evaluating Lactobacillus plantarum 299v, Placebo comparator, and 2 other interventions for Irritable Bowel Syndrome. Completed, enrolled 81 participants across 1 site.

Detailed Summary

In patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy and will the probiotic influence gut microflora and thus improve clinical outcomes, as compared to no intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesSouth Africa
CollaboratorsNestlè Nutrition Institute Africa, National Research Foundation (NRF) (RSA)

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 26, 2013
Enrollment StartJan 1, 2011
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.0 years ago

Interventions

Lactobacillus plantarum 299vdrug

two capsules of 5 X 10 \^9 c.f.u each

Placebo comparatordrug

Micro-crystalline cellulose powder, identical taste, texture and appearance

Run in periodother

Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo

Wash - out periodother

Wash - out period following treatment phase of eight weeks