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:
Collaborator:
Dr. Prodeus
Information provided by:
Danone Research
ClinicalTrials.gov Identifier:
NCT01200173
First received: September 10, 2010
Last updated: October 5, 2010
Last verified: September 2010
  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, Occuring in Healthy Children,
Including Upper Respiratory Tract Infections (Defined as
Rhinopharyngitis, Sore Throat, Sinusitis and Otitis), Lower
Respiratory Tract Infections (Defined as Bronchitis,
Pneumopathy and Flu and Flu-like Syndromes), and
Gastrointestinal Tract Infection Defined as Gastroenteritis.
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
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Danone Research:

Study Start Date: October 2006
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

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Dr. Prodeus
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01200173     History of Changes
Other Study ID Numbers: NU206
Study First Received: September 10, 2010
Last Updated: October 5, 2010
Health Authority: Russia: Federal Agency for Healthcare and Social Development

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

Additional relevant MeSH terms:
Bronchitis
Communicable Diseases
Gastroenteritis
Infection
Nasopharyngitis
Respiratory Tract Infections
Bronchial Diseases
Digestive System Diseases
Gastrointestinal Diseases
Lung Diseases
Lung Diseases, Obstructive
Nasopharyngeal Diseases
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Pharyngitis
Respiratory Tract Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 23, 2014