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

This study has been completed.
Information provided by (Responsible Party):
Danone Research Identifier:
First received: September 10, 2010
Last updated: November 23, 2016
Last verified: November 2016
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of the Consumption of a Fermented Milk on Common Infections in Children Aged 3-6 Years, Attending Day Care Centers

Further study details as provided by Danone Research:

Enrollment: 600
Study Start Date: November 2006
Study Completion Date: July 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 = Tested product Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
Sham Comparator: 2 = Control product Other: 2-Non fermented dairy product (control)


Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT01200173

Russian Federation
Federal State Institution "Federal research center of pediatric hematology, oncology and imunology"
Moscow, Russian Federation, 117997
Sponsors and Collaborators
Danone Research
  More Information

Responsible Party: Danone Research Identifier: NCT01200173     History of Changes
Other Study ID Numbers: NU206
Study First Received: September 10, 2010
Last Updated: November 23, 2016

Keywords provided by Danone Research:
Probiotic - Lactobacillus casei DN-114 001 - dairy
product - infections - children

Additional relevant MeSH terms:
Communicable Diseases processed this record on April 28, 2017