Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-s… (NCT01315418) | Clinical Trial Compass
TerminatedNot Applicable
Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
France239 participantsStarted 2006-12
Plain-language 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.
Who can participate
Age range18 Years – 29 Years
SexALL
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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, alcoho…