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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)

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ClinicalTrials.gov Identifier: NCT01097993
Recruitment Status : Completed
First Posted : April 2, 2010
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Women With IBS-C Other: 1-fermented dairy product Other: 2- milk-based non-fermented dairy product (control product) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : February 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : January 2014

Arm Intervention/treatment
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)




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


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

Inclusion Criteria:

  • female
  • Age: 18-70

Exclusion Criteria:


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

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01097993     History of Changes
Other Study ID Numbers: NU324
First Posted: April 2, 2010    Key Record Dates
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