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)

Not Applicable

Completed

• Conditions: Women With IBS-C
• Interventions: Other: 1-fermented dairy product; Other: 2- milk-based non-fermented dairy product (control product)

• Registration Number: NCT01097993
• Lead Sponsor: Danone Research

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-04-01
• Study First Posted: 2010-04-02
• Primary Completion: 2012-06
• Study Completion: 2014-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• female
• Age: 18-70

Exclusion Criteria

• NA

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 = Tested product	1-fermented dairy product	-
2 = Control product	2- milk-based non-fermented dairy product (control product)	-

Primary Outcome Measures

Name	Time	Method
Mean abdominal distension after a 4-week period of product consumption in IBS-C patients	0-4 weeks

Trial Locations

Locations (1)

Manchester Hospital; 🇬🇧 Manchester, United Kingdom