Children Immune Functions(2)

Not Applicable

Completed

• Conditions: Diarrhea; Upper Respiratory Infections
• Interventions: Dietary Supplement: Milk with Bifidobacteria; Dietary Supplement: Milk with non replicating lactobacilli; Dietary Supplement: placebo

• Registration Number: NCT01731392
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-16
• Study First Posted: 2012-11-21
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 604

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Milk with Bifidobacteria	Milk with Bifidobacteria	duration of the treatment is 5 months
Milk with non replicating lactobacilli	Milk with non replicating lactobacilli	duration of the treatment is 5 months
Semi skimmed milk	placebo	duration of the treatment is 5 months

Primary Outcome Measures

Name	Time	Method
Days with diarrhea	during the 5 months of follow up

Secondary Outcome Measures

Name	Time	Method
Number of episodes of Upper Respiratory Infections	5 months
Duration of episodes of Upper Respiratory Infections	5 months
Severity of episodes of Upper Respiratory Infections	5 months

Trial Locations

Locations (1)

Dept. Nutrition, Faculty of Medicine University of Indonesia; 🇮🇩 Jakarta, Indonesia