Effect of Probiotic Supplement on Bowel Function (IBS2)

Danisco

Status and phase: Terminated; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: Probiotic supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT01475929

IBS2

Details and patient eligibility

About

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

Full 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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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149 participants in 3 patient groups, including a placebo group

Probiotic low

Active Comparator group

Description:

Lower dose of probiotic supplement

Treatment:

Dietary Supplement: Probiotic supplement

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Probiotic supplement

Probiotic high

Active Comparator group

Description:

Higher dose of probiotic supplement

Treatment:

Dietary Supplement: Probiotic supplement