Status:
COMPLETED
Effect of the Consumption of a Fermented Milk on Common Infections in Children Aged 3-6 Years, Attending Day Care Centers
Lead Sponsor:
Danone Global Research & Innovation Center
Conditions:
Common Infectious Diseases
Eligibility:
All Genders
3-6 years
Phase:
NA
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 prod...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01200173
Start Date
November 1 2006
End Date
July 1 2007
Last Update
November 25 2016
Active Locations (1)
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1
Federal State Institution "Federal research center of pediatric hematology, oncology and imunology"
Moscow, Russia, 117997