Effect of Probiotic Fermented Dairy Drinks on Intestinal Immune Response

NCT ID: NCT00987311

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

1-Test product A

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

Group Type: ACTIVE_COMPARATOR

1- Dairy drink containing probiotics A

Intervention Type: DIETARY_SUPPLEMENT

1- Dairy drink containing probiotics A

2-Test product B

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

Group Type: ACTIVE_COMPARATOR

2- Dairy drink containing probiotics B

Intervention Type: DIETARY_SUPPLEMENT

2- Dairy drink containing probiotics B

3-Control

3-Dairy product without probiotics (control)

Group Type: SHAM_COMPARATOR

3- Dairy drink without probiotics (control)

Intervention Type: DIETARY_SUPPLEMENT

3- Dairy drink without probiotics (control)

Interventions

1- Dairy drink containing probiotics A

1- Dairy drink containing probiotics A

Intervention Type: DIETARY_SUPPLEMENT

2- Dairy drink containing probiotics B

2- Dairy drink containing probiotics B

Intervention Type: DIETARY_SUPPLEMENT

3- Dairy drink without probiotics (control)

3- Dairy drink without probiotics (control)

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NU311

Identifier Type: -

Identifier Source: org_study_id