Effect of Probiotic Fermented Dairy Drinks on Intestinal Immune Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00987311
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : January 20, 2017
Information provided by (Responsible Party):
Danone Research

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.

Condition or disease Intervention/treatment Phase
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) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Pilot Study on the Effects of Probiotic Fermented Dairy Drinks on the Intestinal Immune Response in Healthy Adults
Study Start Date : September 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2011

Arm Intervention/treatment
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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Responsible Party: Danone Research Identifier: NCT00987311     History of Changes
Other Study ID Numbers: NU311
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017

Keywords provided by Danone Research:
intestinal immune system
healthy subjects
dairy drink
Healthy adults