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:
Danone Research
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
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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
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 Infection Gastroenteritis Lung Diseases Nasopharyngitis Otitis Pharyngitis Respiratory Tract Infections Sinusitis Common Cold Bronchial Diseases Respiratory Tract Diseases |
Lung Diseases, Obstructive Gastrointestinal Diseases Digestive System Diseases Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases Ear Diseases Paranasal Sinus Diseases Nose Diseases Picornaviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 16, 2013