Conditions: Irritable Bowel Syndrome
Keywords: only constipation and diarrhea predominant no mixed or alternating types
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 81
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Lactobacillus plantarum 299v capsules arm 2: Placebo capsule, filled with micro-crystalline cellulose powder arm 3: Run in period of one to two weeks, no treatment. At baseline randomization and treatment commenced. arm 4: Wash out period of two weeks, no treatment.

Interventions: intervention 1: Lactobacillus plantarum 299v intervention 2: Placebo comparator intervention 3: Run in period intervention 4: Wash - out period
Intervention descriptions: intervention 1: two capsules of 5 X 10 \^9 c.f.u each intervention 2: Micro-crystalline cellulose powder, identical taste, texture and appearance intervention 3: Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo intervention 4: Wash - out period following treatment phase of eight weeks

Protocol document: