Effect of Probiotic Supplement on Bowel Function

Irritable Bowel Syndrome Clinical Trial

— IBS2  

Official title:

Effect of Probiotic Supplement on Bowel Function

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01475929
• Other study ID #: IBS2
• Status: Terminated
• Phase: Phase 2
• First received: September 20, 2011
• Last updated: August 11, 2015
• Start date: June 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2015
• 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 probiotic supplement on symptoms of irritable bowel syndrome.

Description:

The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on symptoms of irritable bowel syndrome (IBS). Fulfillment of Rome III criteria will be used as inclusion criterion. Subjective assessment of bowel symptoms, IBS-related quality of life and adequate relief will be assessed as outcome measures.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 149
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects aged 18 to 65 with functional bowel symptoms and 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 are exclusion criteria.

Study Design

Allocation: Randomized, Endpoint Classification: 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 supplement
A single strain probiotic supplement given at two doses

Locations

Country	Name	City	State
Finland	Herttoniemi Hospital	Helsinki

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, 6 weeks, 12 weeks	No
Secondary	Change in quality of life	Validated questionnaire	0 weeks, 6 weeks, 12 weeks	No
Secondary	Adequate relief	Weekly question	Weekly over 3 month intervention	No
Secondary	Change in faecal microbiota	Quantification of selected microbes and the intervention strain from faecal samples	0 weeks, 6 weeks, 12 weeks	No