NCT01886781

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

Randomised Controlled Trial: Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: University of Stellenbosch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Conduct a study on nutrient intakes gastrointestinal microbiota and the effect of a probiotic, Lactobacillus plantarum 299v in irritable bowel syndrome patients.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-06-26
• Last updated: 2014-09-29
• Results posted: 2014-09-29

Locations

1 site across 1 country: South Africa