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Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome

NCT01886781 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2014-09-29

Study results available
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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.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Lactobacillus plantarum 299v

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

DRUG

Placebo comparator

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

OTHER

Run in period

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

OTHER

Wash - out period

Wash - out period following treatment phase of eight weeks

Sponsors & Collaborators

  • Nestlè Nutrition Institute Africa

    collaborator OTHER

  • National Research Foundation (NRF) (RSA)

    collaborator UNKNOWN

  • University of Stellenbosch

    lead OTHER

Principal Investigators

  • Cheryl Stevenson, M.Sc · Univeristy of Stellenbosch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • South Africa

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 NCT01886781 on ClinicalTrials.gov