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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01731392
Other study ID # 10.50.NRC
Secondary ID
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


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
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