Effect of Probiotic Fermented Dairy Drinks on Intestinal Immune Response

This study has been completed.

First Received on September 28, 2009. Last Updated on June 15, 2011 History of Changes

Sponsor:	Danone Research
Collaborator:	Istituto Clinico Humanitas
Information provided by:	Danone Research
ClinicalTrials.gov Identifier:	NCT00987311

Purpose

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.

Condition	Intervention
Healthy	Dietary Supplement: 1- Dairy drink containing probiotics A Dietary Supplement: 2- Dairy drink containing probiotics B Dietary Supplement: 3- Dairy drink without probiotics (control)

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Pilot Study on the Effects of Probiotic Fermented Dairy Drinks on the Intestinal Immune Response in Healthy Adults

Further study details as provided by Danone Research:

Estimated Enrollment:	33
Study Start Date:	September 2009
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1-Test product A 1-Dairy product containing probiotics A (test product A)	Dietary Supplement: 1- Dairy drink containing probiotics A 1- Dairy drink containing probiotics A
Active Comparator: 2-Test product B 2-Dairy product containing probiotics B (test product B)	Dietary Supplement: 2- Dairy drink containing probiotics B 2- Dairy drink containing probiotics B
Sham Comparator: 3-Control 3-Dairy product without probiotics (control)	Dietary Supplement: 3- Dairy drink without probiotics (control) 3- Dairy drink without probiotics (control)

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Silvio Danese, MD, PhD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:	NCT00987311 History of Changes
Other Study ID Numbers:	NU311
Study First Received:	September 28, 2009
Last Updated:	June 15, 2011
Health Authority:	Italy: Ethics Committee

Keywords provided by Danone Research:

Probiotics
intestinal immune system
human

healthy subjects
dairy drink
Healthy adults

ClinicalTrials.gov processed this record on February 09, 2012