Effect of Probiotic Fermented Dairy Drinks on Intestinal Immune Response

Danone

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: 3- Dairy drink without probiotics (control); Dietary Supplement: 1- Dairy drink containing probiotics A; Dietary Supplement: 2- Dairy drink containing probiotics B

Study type: Interventional

Funder types: Industry

Identifiers

NCT00987311

NU311

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 3 patient groups

1-Test product A

Active Comparator group

Description:

1-Dairy product containing probiotics A (test product A)

Treatment:

Dietary Supplement: 1- Dairy drink containing probiotics A

2-Test product B

Active Comparator group

Description:

2-Dairy product containing probiotics B (test product B)

Treatment:

Dietary Supplement: 2- Dairy drink containing probiotics B

3-Control

Sham Comparator group

Description:

3-Dairy product without probiotics (control)

Treatment:

Dietary Supplement: 3- Dairy drink without probiotics (control)