Effect of Probiotic Fermented Dairy Drinks on Intestinal Immune Response

NCT00987311 | Completed

• 1 other identifier: NU311
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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

Keywords

Probiotics; intestinal immune system; human; healthy subjects; dairy drink; Healthy adults

Study Arms (3)

1-Test product A

ACTIVE COMPARATOR

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

Dietary Supplement: 1- Dairy drink containing probiotics A

2-Test product B

ACTIVE COMPARATOR

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

Dietary Supplement: 2- Dairy drink containing probiotics B

3-Control

SHAM COMPARATOR

3-Dairy product without probiotics (control)

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

Interventions

1- Dairy drink containing probiotics A DIETARY_SUPPLEMENT

1- Dairy drink containing probiotics A

1-Test product A

2- Dairy drink containing probiotics B DIETARY_SUPPLEMENT

2- Dairy drink containing probiotics B

2-Test product B

3- Dairy drink without probiotics (control) DIETARY_SUPPLEMENT

3- Dairy drink without probiotics (control)

3-Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2009
• First Posted: September 30, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2011
• Last Updated: January 20, 2017

Record last verified: 2017-01