Effect of Probiotic Supplement on Bowel Function

NCT01475929 — Phase 2, Terminated, 149 participants, Danisco

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Registry	NCT01475929, acronym IBS2
Status	Terminated - Protocol violations
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, supportive care
Enrollment	149 (Actual)
Sponsor	Danisco (Industry)
Conditions	Irritable Bowel Syndrome
Interventions	Probiotic supplement (Dietary supplement)
Dates	start 2011-06-01, primary completion 2012-05-01, completion 2012-05-01, first posted 2011-11-22, last updated 2015-08-13
Locations	1 site in Finland

-Summary

The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.

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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
Probiotic low	Active comparator	Dietary Supplement: Probiotic supplement	Lower dose of probiotic supplement
Placebo	Placebo comparator	Dietary Supplement: Probiotic supplement
Probiotic high	Active comparator	Dietary Supplement: Probiotic supplement	Higher dose of probiotic supplement

Probiotic supplement (Dietary supplement), also known as Lactobacillus: A single strain probiotic supplement given at two doses

+Outcome measures

Primary outcomes

Change in functional bowel symptoms [0 weeks, 6 weeks, 12 weeks]: Validated questionnaire

Secondary outcomes

Change in quality of life [0 weeks, 6 weeks, 12 weeks]: Validated questionnaire
Adequate relief [Weekly over 3 month intervention]: Weekly question
Change in faecal microbiota [0 weeks, 6 weeks, 12 weeks]: Quantification of selected microbes and the intervention strain from faecal samples

+Eligibility

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Herttoniemi Hospital	Helsinki, Helsinki	Finland

+Investigators

Arthur Ouwehand, PhD, Study chair, Danisco
Anna Lyra, PhD, Study director, Danisco
Lea Veijola, MD, Principal investigator, Helsinki Health Centre
Sampo Lahtinen, PhD, Study chair, Danisco
Anneli Tarpila, PhD, Study director, Danisco