Effect of Probiotic Fermented Dairy Drinks on Intestinal Immune Response

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: 1- Dairy drink containing probiotics A
* Dietary Supplement: 2- Dairy drink containing probiotics B
* Dietary Supplement: 3- Dairy drink without probiotics (control)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1-Test product A<br>1-Dairy product containing probiotics A (test product A) | Dietary Supplement: 1- Dairy drink containing probiotics A<br>* 1- Dairy drink containing probiotics A<br>|
| Active Comparator: 2-Test product B<br>2-Dairy product containing probiotics B (test product B) | Dietary Supplement: 2- Dairy drink containing probiotics B<br>* 2- Dairy drink containing probiotics B<br>|
| Sham Comparator: 3-Control<br>3-Dairy product without probiotics (control) | Dietary Supplement: 3- Dairy drink without probiotics (control)<br>* 3- Dairy drink without probiotics (control)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, intestinal immune system, human, healthy subjects, dairy drink, Healthy adults