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

This study has been completed.
Sponsor:
Collaborator:
RPS Research France
Information provided by:
Danone Research
ClinicalTrials.gov Identifier:
NCT01388010
First received: July 3, 2011
Last updated: July 5, 2011
Last verified: July 2011
  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 the improvement of gastrointestinal well being and digestive symptoms in adult women reporting minor digestive troubles among the general population.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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"

Further study details as provided by Danone Research:

Estimated Enrollment: 380
Study Start Date: September 2009
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388010

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

No publications provided

ClinicalTrials.gov Identifier: NCT01388010     History of Changes
Other Study ID Numbers: NU325
Study First Received: July 3, 2011
Last Updated: July 5, 2011
Health Authority: France: AFSSAPS

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

ClinicalTrials.gov processed this record on April 22, 2014