We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01388010
First Posted: July 6, 2011
Last Update Posted: October 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Danone Research
July 3, 2011
July 6, 2011
October 27, 2016
September 2009
December 2009   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01388010 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of the Effect of a Fermented Dairy Product on Gastrointestinal Well Being in Adult Women
"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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Healthy Adult Women
  • Other: 1-Fermented Probiotic Dairy Product (test)
  • Other: 2-Milk-based non-fermented dairy product(control)
  • Experimental: 1 = Test product
    Arm 1 - Intervention 1 (probiotics)
    Intervention: Other: 1-Fermented Probiotic Dairy Product (test)
  • 2 = Control product
    Arm 2 - Intervention 2 (control)
    Intervention: Other: 2-Milk-based non-fermented dairy product(control)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
336
October 2010
December 2009   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01388010
NU325
No
Not Provided
Not Provided
Danone Research
Danone Research
Not Provided
Not Provided
Danone Research
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP