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"

NCT01388010•Danone Global Research & Innovation Center

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 60 years

Sex

FEMALE

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)

Locations (1)

RPS Research France

Caen, France

Key Dates

Start Date

September 1, 2009

Primary Completion Date

December 1, 2009

Completion Date

October 1, 2010

Last Updated

October 27, 2016

Enrollment

336

ACTUAL participants

Conditions

Healthy Adult Women

Interventions

1-Fermented Probiotic Dairy Product (test)

OTHER

2-Milk-based non-fermented dairy product(control)

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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