Common Infectious Diseases Clinical Trial
Official title:
Effect of the Consumption of a Fermented Milk on Common Infections in Children Aged 3-6 Years, Attending Day Care Centers
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) in children aged 3-6 years, attending day care centers.Volunteers received either 200g/day of tested product (N=300) or control product (N=299) for 3-months, followed by a 1-month follow-up.
| Status | Completed |
| Enrollment | 600 |
| Est. completion date | July 2007 |
| Est. primary completion date | April 2007 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 3 Years to 6 Years |
| Eligibility |
Inclusion Criteria: - Subject whose parents/legal guardians had given written informed consent, - Male or female, aged 3 to 6 years (upper bound excluded), - Attending day-care centres or preschools 5 days a week in the Moscow area, - Subject found medically healthy (in particular, free of respiratory and GI tract symptoms), - Subject who appreciated dairy products and multi-fruit flavour. Exclusion Criteria: - Subject whose parents were not reading and writing Russian, or not understanding informed consent or study protocol. - Subject with allergy or hypersensitivity to milk proteins or dairy foods components (ex: lactose, milk proteins), 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 could interfere with the outcome of the study (Ex: HIV, Chemotherapy, malabsorption, ulcer, celiac disease, failure to thrive…). - Subject having experienced any infectious disease during the last 7 days. - Subject with current diarrhoea or constipation Subject who was frequently using laxatives or who had 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…). - Subject currently receiving, or who had 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 antiinflammatory substances, immunosuppressant treatment… - Subject already enrolled in another clinical study, or currently under an exemption period from a previous 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Federal State Institution "Federal research center of pediatric hematology, oncology and imunology" | Moscow |
| Lead Sponsor | Collaborator |
|---|---|
| Danone Research |
Russian Federation,