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

Danone Research1 site in 1 country239 target enrollmentDecember 2006

ConditionsUpper Respiratory Tract Infections Rhinopharyngitis Sore Throat Sinusitis Otitis Lower Respiratory Tract Infections Bronchitis Pneumopathy Flu Flu-like Syndromes Gastroenteritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Upper Respiratory Tract Infections
Sponsor: Danone Research
Enrollment: 239
Locations: 1
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

July 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Danone Research

Responsible Party

Sponsor

Eligibility Criteria

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