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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014