Children Immune Functions(2)

Société des Produits Nestlé (SPN)604 enrolled

Overview

To investigate the effect of milk-based formulas on infections and immune functions in healthy children.

Particular attention was paid to the role played by nutrition in supporting the gut ecosystem, balancing microbiota and promoting health status. In that respect, the beneficial effects of probiotics were demonstrated for different infectious diseases, GII and URI. The beneficial effect of probiotics for treatment of symptomatic diarrhea was clearly documented.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

604

Conditions

Diarrhea Upper Respiratory Infections

Interventions

Milk with BifidobacteriaDIETARY_SUPPLEMENT

A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.

Milk with non replicating lactobacilliDIETARY_SUPPLEMENT

A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.

placeboDIETARY_SUPPLEMENT

A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.

Eligibility

Sex: ALLMin age: 1 YearMax age: 3 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Parents written and signed informed consent for participation in the study. * Healthy children aged 1 to 3 years that are no more breastfed. * Go to a selected nursery and / or pediatrician. * Parents must have a phone at home or a cellular phone to call the paediatrician. * No consumption of commercial products containing probiotics or prebiotics during the 3 weeks before and during the study period. * Parents are able to give their children, twice daily, 2 milk servings on a 5 months period. * Children not being intensive consumers of regular yoghurts Exclusion Criteria: * Rotavirus and flu vaccines administration within the last 3 months prior to V1 (baseline visit). * Used antibiotics within the last 30 days prior to V1 (baseline visit). * Congenital or chronic disease. * Any kind of immunodeficiency or allergy, milk protein allergy or lactose intolerance. * Significant illness within the two weeks prior to start of the study or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.

Locations (1)

Dept. Nutrition, Faculty of Medicine University of Indonesia

Jakarta, Indonesia

Outcomes

Primary Outcomes

Days with diarrhea

Time frame: during the 5 months of follow up

Secondary Outcomes

Number of episodes of Upper Respiratory Infections

Time frame: 5 months

Duration of episodes of Upper Respiratory Infections

Time frame: 5 months

Severity of episodes of Upper Respiratory Infections

Time frame: 5 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.