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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01097993
First Posted: April 2, 2010
Last Update Posted: January 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Danone Research
  Purpose
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).

Condition Intervention
Women With IBS-C Other: 1-fermented dairy product Other: 2- milk-based non-fermented dairy product (control product)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Further study details as provided by Danone Research:

Primary Outcome Measures:
  • Mean abdominal distension after a 4-week period of product consumption in IBS-C patients [ Time Frame: 0-4 weeks ]

Enrollment: 120
Study Start Date: February 2010
Study Completion Date: January 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 = Tested product Other: 1-fermented dairy product
Arm 1 - Intervention 1 (probiotics)
Active Comparator: 2 = Control product Other: 2- milk-based non-fermented dairy product (control product)
Arm 2 - Intervention 2 (control)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female
  • Age: 18-70

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097993


Locations
United Kingdom
Manchester Hospital
Manchester, United Kingdom
Sponsors and Collaborators
Danone Research
  More Information

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01097993     History of Changes
Other Study ID Numbers: NU324
First Submitted: March 29, 2010
First Posted: April 2, 2010
Last Update Posted: January 20, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases