Who is sponsoring NCT01886781?

NCT01886781 is sponsored by University of Stellenbosch.

What condition does NCT01886781 study?

NCT01886781 studies Irritable Bowel Syndrome.

What drugs are being tested in NCT01886781?

Interventions: Lactobacillus plantarum 299v, Placebo comparator, Run in period, Wash - out period.

What is the status of NCT01886781?

NCT01886781 is currently COMPLETED.

Last reviewed 2014-09-24 · How we verify

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

NCT01886781 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	University of Stellenbosch
Phase	Phase 4
Status	COMPLETED
Enrolment	81
Start date	2011-01
Completion	2013-06

Conditions

Irritable Bowel Syndrome

Interventions

Lactobacillus plantarum 299v
Placebo comparator
Run in period
Wash - out period

Primary outcomes

A Change in Abdominal Pain Severity — Total trial period 12 weeks
The clinical severity of the IBS symptoms (pain and distension) was evaluated by the Francis Severity Score questionnaire (Francis 1997). The questionnaire is a validated tools for use in IBS. The severity score contained five questions, each given a value from 0 (no symptoms) to 100 (most severe) for measuring the severity and frequency of abdominal pain. The sum of scores of these questions was considered the severity score, with a maximum possible score of 500

Countries

South Africa