Bronchitis, Flu, Flu-like Syndromes, Gastroenteritis, Lower Respiratory Tract Infections, Otitis, Pneumopathy, Rhinopharyngitis, Sinusitis, Sore Throat, Upper Respiratory Tract Infections
Conditions
Keywords
Probiotic - Lactobacillus casei DN-114 001 - dairy product -, infections - firemen, Common infectious diseases, occuring in healthy subjects,, including upper respiratory tract infections (defined as, rhinopharyngitis, sore throat, sinusitis and otitis), lower respiratory tract infections (defined as bronchitis, pneumopathy and flu and flu-like syndromes), gastrointestinal tract infection defined as gastroenteritis
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.
Interventions
Sponsors
Danone Global Research & Innovation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes
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
Countries
France
Outcome results
None listed