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

NCT01200173 | Completed

• 1 other identifier: NU206
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Infectious Diseases

Keywords

Probiotic - Lactobacillus casei DN-114 001 - dairy; product - infections - children

Study Arms (2)

1 = Tested product

ACTIVE COMPARATOR

Other: 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)

2 = Control product

SHAM COMPARATOR

Other: 2-Non fermented dairy product (control)

Interventions

1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®) OTHER

1 = Tested product

2-Non fermented dairy product (control) OTHER

2 = Control product

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danone Global Research & Innovation Center: lead

Study Sites (1)

Federal State Institution "Federal research center of pediatric hematology, oncology and imunology"

Moscow, 117997, Russia

Location

Related Publications (1)

• 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.

  PMID: 27168455 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 13, 2010
• Study Start: November 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: July 1, 2007
• Last Updated: November 25, 2016

Record last verified: 2016-11

Locations

RU (1)