Children Immune Functions(2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01731392
First received: November 16, 2012
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Diarrhea
Upper Respiratory Infections
Dietary Supplement: Milk with Bifidobacteria
Dietary Supplement: Milk with non replicating lactobacilli
Dietary Supplement: placebo

Study Type: Interventional
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
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

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Days with diarrhea [ Time Frame: during the 5 months of follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of episodes of Upper Respiratory Infections [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Duration of episodes of Upper Respiratory Infections [ Time Frame: 5 months ] [ Designated as safety issue: No ]
  • Severity of episodes of Upper Respiratory Infections [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 604
Study Start Date: November 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   1 Year to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731392

Locations
Indonesia
Dept. Nutrition, Faculty of Medicine University of Indonesia
Jakarta, Indonesia
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Saptawati Bardosono, MSc Nutrition Department, Faculty of Medicine,
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01731392     History of Changes
Other Study ID Numbers: 10.50.NRC
Study First Received: November 16, 2012
Last Updated: December 11, 2013
Health Authority: Indonesia: Ethics Committee

Keywords provided by Nestlé:
Diarrhea
Children
Lactobacilli

Additional relevant MeSH terms:
Diarrhea
Respiratory Tract Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 15, 2014