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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:
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01097993
First received: March 29, 2010
Last updated: January 18, 2017
Last verified: January 2017
  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

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
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
  More Information

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01097993     History of Changes
Other Study ID Numbers: NU324
Study First Received: March 29, 2010
Last Updated: January 18, 2017

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 August 17, 2017