Study of the Effect of a Fermented Dairy Product on Gastrointestinal Well Being in Adult Women

October 26, 2016 updated by: Danone Research

"Effect of the Consumption of a Fermented Dairy Product on Gastrointestinal Well-being in a Healthy Population of Women With Minor Digestive Symptoms"

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 the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

336

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14052
        • RPS Research France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female free-living subject aged from 18 to 60 years.
  • Subject with a body mass index between 18 and 30.
  • Subject with minor digestive symptoms as defined by screening questionnaire of frequency of digestive symptoms.
  • Subject with normal stool frequency

Exclusion Criteria:

  • Subject with a diagnosis of Irritable Bowel Syndrome (IBS) or other functional bowel disease (constipation, diarrhoea…)
  • Subject with known organic disease, including an inflammatory bowel disease, a benign or malign tumour of intestine or colon and significant systemic disease
  • Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs
  • Subject having taken antibiotics in the last 4 weeks
  • Pregnant subject or subject planning to become pregnant during the study; breast-feeding subject.
  • Subject with known lactose intolerance or immunodeficiency
  • Subject with known allergy to product component (milk protein for example)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 = Test product
Arm 1 - Intervention 1 (probiotics)
Other: 1-Fermented Probiotic Dairy Product (test)
Other: 2 = Control product
Arm 2 - Intervention 2 (control)
Other: 2-Milk-based non-fermented dairy product(control)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danone Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

July 3, 2011

First Submitted That Met QC Criteria

July 5, 2011

First Posted (Estimate)

July 6, 2011

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NU325

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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