Children Immune Functions(2)

December 11, 2013 updated by: Nestlé

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

604

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • Dept. Nutrition, Faculty of Medicine University of Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Milk with Bifidobacteria
duration of the treatment is 5 months
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.
ACTIVE_COMPARATOR: Milk with non replicating lactobacilli
duration of the treatment is 5 months
Dietary supplement: 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_COMPARATOR: Semi skimmed milk
duration of the treatment is 5 months
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Days with diarrhea
Time Frame: during the 5 months of follow up
during the 5 months of follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of episodes of Upper Respiratory Infections
Time Frame: 5 months
5 months
Duration of episodes of Upper Respiratory Infections
Time Frame: 5 months
5 months
Severity of episodes of Upper Respiratory Infections
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nestlé

Investigators

  • Principal Investigator: Saptawati Bardosono, MSc, Nutrition Department, Faculty of Medicine,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

November 16, 2012

First Posted (ESTIMATE)

November 21, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 12, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.50.NRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diarrhea

Clinical Trials on Milk with Bifidobacteria

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe