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

Danone

Status

Terminated

Conditions

Otitis

Flu-like Syndromes

Sore Throat

Gastroenteritis

Bronchitis

Upper Respiratory Tract Infections

Flu

Pneumopathy

Rhinopharyngitis

Lower Respiratory Tract Infections

Sinusitis

Treatments

Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)

Other: 2-Non fermented dairy product (control)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01315418

NU201

Details and patient eligibility

About

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.

Enrollment

239 patients

Sex

All

Ages

18 to 29 years old

Volunteers

Accepts Healthy Volunteers

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