Pilot Study on the Effects of Probiotic Fermented Dairy Drinks on the Intestinal Immune Response in Healthy Adults

Danone Research0 sites33 target enrollmentSeptember 2009

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Danone Research
Enrollment: 33
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate whether two different fermented dairy drinks consumed daily could have an effect on the intestinal immune response in healthy subjects.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

December 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Danone Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male/female subjects aged from 18 to 45 years (bounds included).
•Subjects with none of the symptoms of gastrointestinal infectious diseases
•Subjects with a body mass index (BMI) between 19 and 30 kg/m² (bounds included).
•Subjects who accept to be submitted to an alimentary restriction of product with OTC and foods containing probiotics and/or prebiotics
•Subjects who regularly consume and appreciate dairy products
•Subjects who have not consumed any products or OTCs containing probiotics within the last three months.

Exclusion Criteria

•Subjects in a situation that, in the investigator opinion, could interfere with optimal participation in the present study (e.g. non dairy-products consumer) or could constitute a special risk for the subject.
•Subjects with allergies or hypersensitivity to any component of the study product (e.g: allergy or hypersensitivity to milk proteins, or lactose intolerance)
•Subjects with any food allergy
•Subjects with auto-immune or with chronic disease or with a history of chronic metabolic or gastrointestinal.
•Subjects who have had any surgery or intervention requiring general anaesthesia in the last 4 weeks..
•Subjects with special diet requirements
•For female subjects: pregnancy, breast feeding or no method of contraceptive used
•Subjects participating in any other interventional study concomitantly or within 4 weeks of the study entry date.