Effect of the Consumption of a Fermented Milk on Common Infections in Children Aged 3-6 Years, Attending Day Care Centers
Primary Purpose
Common Infectious Diseases
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
2-Non fermented dairy product (control)
Sponsored by
About this trial
This is an interventional basic science trial for Common Infectious Diseases focused on measuring Probiotic - Lactobacillus casei DN-114 001 - dairy, product - infections - children
Eligibility 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.
Sites / Locations
- Federal State Institution "Federal research center of pediatric hematology, oncology and imunology"
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
1 = Tested product
2 = Control product
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01200173
Brief Title
Effect of the Consumption of a Fermented Milk on Common Infections in Children Aged 3-6 Years, Attending Day Care Centers
Official Title
Effect of the Consumption of a Fermented Milk on Common Infections in Children Aged 3-6 Years, Attending Day Care Centers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Danone Research
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Infectious Diseases
Keywords
Probiotic - Lactobacillus casei DN-114 001 - dairy, product - infections - children
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 = Tested product
Arm Type
Active Comparator
Arm Title
2 = Control product
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)
Intervention Type
Other
Intervention Name(s)
2-Non fermented dairy product (control)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Federal State Institution "Federal research center of pediatric hematology, oncology and imunology"
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
12. IPD Sharing Statement
Citations:
PubMed Identifier
27168455
Citation
Prodeus A, Niborski V, Schrezenmeir J, Gorelov A, Shcherbina A, Rumyantsev A. Fermented Milk Consumption and Common Infections in Children Attending Day-Care Centers: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2016 Nov;63(5):534-543. doi: 10.1097/MPG.0000000000001248.
Results Reference
derived
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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
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