Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728610
• Other study ID #: IBS-2
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2012
• Last updated: January 25, 2016
• Start date: October 2012
• Est. completion date: November 2014

Study information

• Verified date: January 2016
• Source: Danisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 391
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• Probiotic (Active high)
Higher dose of probiotic supplement
• Probiotic (Active low)
Lower dose of probiotic supplement
• Placebo
Placebo

Locations

Country	Name	City	State
Finland	Mehiläinen Töölö	Helsinki
Finland	Mehiläinen Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Danisco

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional bowel symptoms	Validated questionnaire	0 weeks, 4 weeks, 12 weeks	No
Secondary	Change in quality of life	Validated questionnaire	0 weeks, 4 weeks, 12 weeks	No
Secondary	Change in anxiety and depression	Validated questionnaire	0 weeks, 4 weeks and 12 weeks	No
Secondary	Adequate relief	Weekly question	Weekly over 3 month intervention	No
Secondary	Change in faecal microbiota	Detection and quantification of microbes from faecal samples	0 weeks, 4 weeks, 12 weeks	No
Secondary	Safety of investigational product	Recording of adverse events and serious adverse events	Throughout the intervention phase	Yes