Diarrhea, Upper Respiratory Infections
Conditions
Keywords
Diarrhea, Children, Lactobacilli
Brief summary
To investigate the effect of milk-based formulas on infections and immune functions in healthy children.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTMilk with Bifidobacteria
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.
DIETARY_SUPPLEMENTMilk with non replicating lactobacilli
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.
DIETARY_SUPPLEMENTplacebo
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.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 3 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days with diarrhea | during the 5 months of follow up |
Secondary
| Measure | Time frame |
|---|---|
| Duration of episodes of Upper Respiratory Infections | 5 months |
| Number of episodes of Upper Respiratory Infections | 5 months |
| Severity of episodes of Upper Respiratory Infections | 5 months |
Countries
Indonesia
Outcome results
None listed