Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms

Danisco

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotic (Active low); Dietary Supplement: Probiotic (Active high)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01728610

IBS-2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 391 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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391 participants in 3 patient groups, including a placebo group

Active high

Active Comparator group

Description:

Probiotic, high dose

Treatment:

Dietary Supplement: Probiotic (Active high)

Active low

Active Comparator group

Description:

Probiotic, low dose

Treatment:

Dietary Supplement: Probiotic (Active low)

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo