Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation

This study has been terminated.

Sponsor:

Collaborator:

Dr Cédric ERNOUF

Information provided by:

Danone Research

ClinicalTrials.gov Identifier:

NCT01315418

First received: March 14, 2011

Last updated: May 3, 2011

Last verified: May 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 14, 2011
Last Updated Date	May 3, 2011
Start Date ^ICMJE	December 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01315418 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
Official Title ^ICMJE	Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
Brief Summary	This multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of respiratory and gastro-intestinal common infectious diseases (cumulated number of infections during the intervention period: primary criteria), and on the Quality of Life in adults submitted to multi-stressor situation. Volunteers received either 200g/day of tested product (N=121) or control product (N=118) for 7-weeks.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Masking: Double-Blind Primary Purpose: Basic Science
Condition ^ICMJE	Upper Respiratory Tract Infections Rhinopharyngitis Sore Throat Sinusitis Otitis Lower Respiratory Tract Infections Bronchitis Pneumopathy Flu Flu-like Syndromes Gastroenteritis
Intervention ^ICMJE	Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) Other: 2-Non fermented dairy product (control)
Study Arm (s)	Active Comparator: 1 = Tested product Intervention: Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) Sham Comparator: 2 = Control product Intervention: Other: 2-Non fermented dairy product (control)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: male and female aged 18-29 years attending 7 weeks of firemen training school a 19 to 29 kg/m2 body mass index found medically healthy (in particular, free of respiratory and GI tract symptoms) agreeing to a written informed consent, and who appreciates dairy products and multi-fruit flavour. Exclusion Criteria: Subject who is not reading and writing French, or not understanding informed consent or study protocol subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose), or with any known food or respiratory allergy; subject presenting a severe evolutive or chronic pathology (Ex: cancer, tuberculosis, Crohn disease, cirrhosis, multiple sclerosis, Type I diabetes…) or any past or actual health condition that may interfere with the outcome of the study (Ex: HIV, Chemotherapy, malabsorption, ulcer, celiac disease…) subject having experienced any infectious disease during the last 7 days subject with current diarrhoea or constipation subject who is frequently using laxatives or who has been using laxatives during the week prior his participation to the study subject who was under artificial nutrition, had gastro-intestinal surgery or any intervention requiring general anaesthesia the last 2 months prior to his participation to the study subject with special medicated diet (obesity, anorexia, metabolic pathology, nutritional complementation…) or with eating disorders (anorexia, bulimia, alcoholism…) subject currently receiving, or who has received during the last months, systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, antiseptics,antifungal, corticoids, vaccines, anti-histaminic molecules, non-corticoid anti-inflammatory substances, immunosuppressant treatment… subject already enrolled in another clinical study, or currently under an exemption period from a previous study female subject who is currently pregnant or breast-feeding, or willing to become pregnant during the 2 coming months after enrolment in the study subject in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject
Gender	Both
Ages	18 Years to 29 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01315418
Other Study ID Numbers ^ICMJE	NU201
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Danone Research
Collaborators ^ICMJE	Dr Cédric ERNOUF
Investigators ^ICMJE	Not Provided
Information Provided By	Danone Research
Verification Date	May 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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