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

Danone

Status

Completed

Conditions

Healthy Adult Women

Treatments

Other: 1-Fermented Probiotic Dairy Product (test)

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT01388010

NU325

Details and patient eligibility

About

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.

Enrollment

336 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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)