Effect of the Consumption of a Fermented Milk on Common Infections in Children Aged 3-6 Years, Attending Day Care Centers

Not Applicable

Completed

• Conditions: Common Infectious Diseases
• Interventions: Other: 2-Non fermented dairy product (control); Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)

• Registration Number: NCT01200173
• Lead Sponsor: Danone Research

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) 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2007-04
• Study Completion: 2007-07
• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 = Control product	2-Non fermented dairy product (control)	-
1 = Tested product	1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)	-

Trial Locations

Locations (1)

Federal State Institution "Federal research center of pediatric hematology, oncology and imunology"; 🇷🇺 Moscow, Russian Federation