A Single-centre, Randomised, Double-blind, Controlled, Parallel-group Study to Evaluate the Effect of a Fermented Dairy Product on Abdominal Distension, Digestive Symptoms and Rectal Sensitivity in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Danone Global Research & Innovation Center120 enrolled

Overview

The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on abdominal distension in IBS patients with constipation (IBS-C).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Women With IBS-C

Interventions

1-fermented dairy productOTHER

Arm 1 - Intervention 1 (probiotics)

Arm 2 - Intervention 2 (control)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * female * Age: 18-70 Exclusion Criteria: * NA

Locations (1)

Manchester Hospital

Manchester, United Kingdom

Outcomes

Primary Outcomes

Mean abdominal distension after a 4-week period of product consumption in IBS-C patients

Time frame: 0-4 weeks

Data from ClinicalTrials.gov

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