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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:
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

July 3, 2011
July 5, 2011
September 2009
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Complete list of historical versions of study NCT01388010 on ClinicalTrials.gov Archive Site
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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
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
380
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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)
Female
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01388010
NU325
No
Not Provided
Danone Research
RPS Research France
Not Provided
Danone Research
July 2011

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