Acute Respiratory Infection, Diarrheal Disease
Conditions
Brief summary
The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.
Interventions
DIETARY_SUPPLEMENTCow's milk
Powdered Whole Cow's Milk
DIETARY_SUPPLEMENTFollow-On Formula
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
Sponsors
Federal University of Bahia
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 48 Months
Healthy volunteers
Yes
Inclusion criteria
* Child 12-48 months of age * Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization * Signed informed consent
Exclusion criteria
* Child who is receiving predominantly breast-milk * Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization * Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child * Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization * Child's z-score of weight for length/height \< -3 according to World Health Organization criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Episodes of acute respiratory infections and diarrheal disease | 28 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systemic antibiotic use | 28 weeks | — |
| Duration of acute respiratory infection and diarrheal disease | 28 weeks | — |
| Changes in stool patterns | 28 weeks | — |
| Fecal and serum immune markers | 28 weeks | — |
| Occurrence of allergic manifestations | 28 weeks | — |
| Incidence of stool parasites | 28 weeks | — |
| Growth | 28 weeks | — |
| Incidence of adverse events | 28 weeks | The incidence of any adverse event for each participant |
| Acceptance of study product | 28 weeks | Acceptance of study product based on quantity consumed |
| Serum Ferritin and Zinc status | 28 weeks | — |
Countries
Brazil
Outcome results
None listed