NCT01728610

Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms (IBS-2)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 391 (actual)
• Sponsor: Danisco · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to analyse the effect of a probiotic supplement on functional intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).

Detailed description

The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on functional intestinal symptoms among subjects diagnosed with IBS according to Rome III criteria. Subjective assessment of bowel symptoms, quality of life, anxiety and depression and adequate relief will be assessed as with questionnaires as outcome measures. The intestinal microbiota will be analysed from faecal samples.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic (Active high)	Higher dose of probiotic supplement
DIETARY_SUPPLEMENT	Probiotic (Active low)	Lower dose of probiotic supplement
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2012-11-20
• Last updated: 2016-01-26

Locations

2 sites across 1 country: Finland