Status:
COMPLETED
Effect of Probiotic Fermented Dairy Drinks on Intestinal Immune Response
Lead Sponsor:
Danone Global Research & Innovation Center
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00987311
Start Date
September 1 2009
End Date
December 1 2011
Last Update
January 20 2017
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