Diarrhea Clinical Trial
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
Verified date | December 2013 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: Ethics Committee |
Study type | Interventional |
To investigate the effect of milk-based formulas on infections and immune functions in healthy children.
Status | Completed |
Enrollment | 604 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 1 Year to 3 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Indonesia | Dept. Nutrition, Faculty of Medicine University of Indonesia | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Nestlé |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Days with diarrhea | during the 5 months of follow up | No | |
Secondary | Number of episodes of Upper Respiratory Infections | 5 months | No | |
Secondary | Duration of episodes of Upper Respiratory Infections | 5 months | No | |
Secondary | Severity of episodes of Upper Respiratory Infections | 5 months | No |
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