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)

Women With IBS-C Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097993
• Other study ID #: NU324
• Status: Completed
• Phase: N/A
• First received: March 29, 2010
• Last updated: January 18, 2017
• Start date: February 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2017
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• female

• Age: 18-70

Exclusion Criteria:

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Women With IBS-C

Intervention

Other:
• 1-fermented dairy product
Arm 1 - Intervention 1 (probiotics)
• 2- milk-based non-fermented dairy product (control product)
Arm 2 - Intervention 2 (control)

Locations

Country	Name	City	State
United Kingdom	Manchester Hospital	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Danone Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean abdominal distension after a 4-week period of product consumption in IBS-C patients		0-4 weeks