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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danone Research
ClinicalTrials.gov Identifier:
NCT01388010
First received: July 3, 2011
Last updated: October 26, 2016
Last verified: October 2016
  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 (Subject, 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"

Further study details as provided by Danone Research:

Enrollment: 336
Study Start Date: September 2009
Study Completion Date: October 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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   (Adult)
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
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: NCT01388010

Locations
France
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 
Study First Received: July 3, 2011
Last Updated: October 26, 2016
Health Authority: France: AFSSAPS

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

ClinicalTrials.gov processed this record on December 02, 2016