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Children Immune Functions(2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01731392
First Posted: November 21, 2012
Last Update Posted: December 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nestlé
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Number of episodes of Upper Respiratory Infections [ Time Frame: 5 months ]
  • Duration of episodes of Upper Respiratory Infections [ Time Frame: 5 months ]
  • Severity of episodes of Upper Respiratory Infections [ Time Frame: 5 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01731392     History of Changes
Other Study ID Numbers: 10.50.NRC
First Submitted: November 16, 2012
First Posted: November 21, 2012
Last Update Posted: December 12, 2013
Last Verified: December 2013

Keywords provided by Nestlé:
Diarrhea
Children
Lactobacilli

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