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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:
Collaborator:
TFS/Lincoln
Information provided by:
Danone Research
ClinicalTrials.gov Identifier:
NCT01097993
First received: March 29, 2010
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  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-Blind

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Danone Research:

Primary Outcome Measures:
  • Abdominal distension [ Designated as safety issue: No ]
  • To evaluate the effect of Activia (4 weeks, twice a day) on mean abdominal distension in IBS patients with constipation (IBS-C)

Study Start Date: February 2010
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female
  • Age: 18-70

Exclusion Criteria:

  • NA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097993

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

No publications provided

ClinicalTrials.gov Identifier: NCT01097993     History of Changes
Other Study ID Numbers: NU324
Study First Received: March 29, 2010
Last Updated: June 25, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 21, 2013