Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Probiotic (Active high); Dietary Supplement: Probiotic (Active low); Dietary Supplement: Placebo

• Registration Number: NCT01728610
• Lead Sponsor: Danisco

Brief 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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-20
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 391

Inclusion Criteria

• Subjects aged 18 to 65 fulfilling Rome III criteria for IBS will be recruited. Sufficient general health and orientation for participating in the study is required and will be evaluated by the MDs.

Exclusion Criteria

• Diagnosed or suspected organic gastrointestinal diseases or severely impaired general health.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active high	Probiotic (Active high)	Probiotic, high dose
Active low	Probiotic (Active low)	Probiotic, low dose
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change in functional bowel symptoms	0 weeks, 4 weeks, 12 weeks	Validated questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in faecal microbiota	0 weeks, 4 weeks, 12 weeks	Detection and quantification of microbes from faecal samples
Change in anxiety and depression	0 weeks, 4 weeks and 12 weeks	Validated questionnaire
Change in quality of life	0 weeks, 4 weeks, 12 weeks	Validated questionnaire
Adequate relief	Weekly over 3 month intervention	Weekly question
Safety of investigational product	Throughout the intervention phase	Recording of adverse events and serious adverse events

Trial Locations

Locations (2)

Mehiläinen Turku; 🇫🇮 Turku, Finland

Mehiläinen Töölö; 🇫🇮 Helsinki, Finland