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OpenTrials
Completed

NCT Number: NCT01731392

Children Immune Functions(2)

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

Completed

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Key information

Age range

1 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. Nutrition, Faculty of Medicine University of Indonesia

Jakarta, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Milk with Bifidobacteria

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. Days with diarrhea

    Time frame: during the 5 months of follow up

Secondary outcomes

  1. Number of episodes of Upper Respiratory Infections

    Time frame: 5 months

  2. Duration of episodes of Upper Respiratory Infections

    Time frame: 5 months

  3. Severity of episodes of Upper Respiratory Infections

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2012
Registry last updated
Dec 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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