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

Not Applicable

Completed

• Conditions: Healthy Adult Women
• Interventions: Other: 2-Milk-based non-fermented dairy product(control); Other: 1-Fermented Probiotic Dairy Product (test)

• Registration Number: NCT01388010
• Lead Sponsor: Danone Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2009-12
• Study Completion: 2010-10
• Study First Submitted: 2011-07-03
• Study First Submitted QC: 2011-07-05
• Study First Posted: 2011-07-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 336

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 = Control product	2-Milk-based non-fermented dairy product(control)	Arm 2 - Intervention 2 (control)
1 = Test product	1-Fermented Probiotic Dairy Product (test)	Arm 1 - Intervention 1 (probiotics)

Trial Locations

Locations (1)

RPS Research France; 🇫🇷 Caen, France