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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01200173
First Posted: September 13, 2010
Last Update Posted: November 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Danone Research
  Purpose
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 (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)

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200173


Locations
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
ClinicalTrials.gov Identifier: NCT01200173     History of Changes
Other Study ID Numbers: NU206
First Submitted: September 10, 2010
First Posted: September 13, 2010
Last Update Posted: November 25, 2016
Last Verified: November 2016

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

Additional relevant MeSH terms:
Infection
Communicable Diseases