Back to resultsChildren Immune Functions(2)
Primary Purpose
Diarrhea, Upper Respiratory Infections
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Milk with Bifidobacteria
Milk with non replicating lactobacilli
placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Diarrhea focused on measuring Diarrhea, Children, Lactobacilli
Eligibility 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.
Sites / Locations
- Dept. Nutrition, Faculty of Medicine University of Indonesia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Milk with Bifidobacteria
Milk with non replicating lactobacilli
Semi skimmed milk
Arm Description
duration of the treatment is 5 months
duration of the treatment is 5 months
duration of the treatment is 5 months
Outcomes
Primary Outcome Measures
Days with diarrhea
Secondary Outcome Measures
Number of episodes of Upper Respiratory Infections
Duration of episodes of Upper Respiratory Infections
Severity of episodes of Upper Respiratory Infections
Full Information
NCT ID
NCT01731392
First Posted
November 16, 2012
Last Updated
December 11, 2013
Sponsor
Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT01731392
Brief Title
Children Immune Functions(2)
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the effect of milk-based formulas on infections and immune functions in healthy children.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Upper Respiratory Infections
Keywords
Diarrhea, Children, Lactobacilli
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
604 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Milk with Bifidobacteria
Arm Type
Experimental
Arm Description
duration of the treatment is 5 months
Arm Title
Milk with non replicating lactobacilli
Arm Type
Active Comparator
Arm Description
duration of the treatment is 5 months
Arm Title
Semi skimmed milk
Arm Type
Placebo Comparator
Arm Description
duration of the treatment is 5 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk with Bifidobacteria
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk with non replicating lactobacilli
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
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 Outcome Measure Information:
Title
Days with diarrhea
Time Frame
during the 5 months of follow up
Secondary Outcome Measure Information:
Title
Number of episodes of Upper Respiratory Infections
Time Frame
5 months
Title
Duration of episodes of Upper Respiratory Infections
Time Frame
5 months
Title
Severity of episodes of Upper Respiratory Infections
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saptawati Bardosono, MSc
Organizational Affiliation
Nutrition Department, Faculty of Medicine,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Nutrition, Faculty of Medicine University of Indonesia
City
Jakarta
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
Children Immune Functions(2)
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