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

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ClinicalTrials.gov Identifier: NCT01388010
Recruitment Status : Completed
First Posted : July 6, 2011
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Healthy Adult Women Other: 1-Fermented Probiotic Dairy Product (test) Other: 2-Milk-based non-fermented dairy product(control)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: "Effect of the Consumption of a Fermented Dairy Product on Gastrointestinal Well-being in a Healthy Population of Women With Minor Digestive Symptoms"
Study Start Date : September 2009
Primary Completion Date : December 2009
Study Completion Date : October 2010
Arms and Interventions

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

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)
Contacts and Locations

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): NCT01388010

RPS Research France
Caen, France, 14052
Sponsors and Collaborators
Danone Research
More Information

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT01388010     History of Changes
Other Study ID Numbers: NU325
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016

Keywords provided by Danone Research:
gastrointestinal well being
digestive symptoms
healthy population