Children Immune Functions(2)

Diarrhea Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Milk-based Formulas on Infections and Immune Functions in Healthy Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01731392
• Other study ID #: 10.50.NRC
• Status: Completed
• Phase: N/A
• First received: November 16, 2012
• Last updated: December 11, 2013
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 3 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diarrhea
• Respiratory Tract Infections
• Upper Respiratory Infections

Intervention

Dietary Supplement:
• Milk 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.
• Milk 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.
• placebo
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.

Locations

Country	Name	City	State
Indonesia	Dept. Nutrition, Faculty of Medicine University of Indonesia	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days with diarrhea		during the 5 months of follow up	No
Secondary	Number of episodes of Upper Respiratory Infections		5 months	No
Secondary	Duration of episodes of Upper Respiratory Infections		5 months	No
Secondary	Severity of episodes of Upper Respiratory Infections		5 months	No