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_SUPPLEMENTFollow-On Formula
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
DIETARY_SUPPLEMENTCow's milk
Powdered whole cow's milk
Sponsors
Shanghai Children's Medical Center
Shanghai, China
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
36 Months to 48 Months
Healthy volunteers
Yes
Inclusion criteria
* Child 36-48 months of age * Child is currently attending a daycare and has attended for 6 months or less * 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 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 height \< -3 according to World Health Organization criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute respiratory infections and diarrheal disease | 28 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of stool parasites | Baseline and 28 weeks | — |
| Growth | 28 weeks | — |
| 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 immune markers | Baseline and 28 weeks | — |
| Serum Ferritin status | Baseline and 28 weeks | — |
| Allergic manifestations | 28 weeks | — |
| Systemic antibiotic use | 28 weeks | — |
| Duration of acute respiratory infection and diarrheal disease | 28 weeks | — |
| Changes in stool patterns | Baseline and 28 weeks | — |
| Fecal immune markers | Baseline and 28 weeks | — |
| Serum zinc status | Baseline and 28 weeks | — |
Countries
China
Outcome results
None listed