None listed
Conditions
Interventions
Group 1 Type of group
bovine lactoferrin 0.5 g or twice a day, daily for 6 months
Group name:Group 2 Type of group
Placebo (maltodextrin 0.5 g), twice a day, daily for 6 months
Sponsors
NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT,
Eligibility
Inclusion criteria
Inclusion criteria: • Children of both sexes, 12 to 18 months of age living in the District of Independence in Lima, Peru may be included in the study. • Children previously weaned for at least a week may be included in the study.
Exclusion criteria
Exclusion criteria: • Children with exclusive or partial breastfeeding will be excluded. Breastfeeding will be promoted until 24 months of age. • Children with chronic or persistent diarrhea • Children with severe malnutrition {defined by weight for height <-3 DS, height for age <-3 DS) • Children with serious infections who required hospitalization during the month before the study (eg, meningitis, pneumonia, bacteremia) • Children with HIV (data obtained from parents or medical records) • Children with chronic underlying diseases (eg: cancer, immunosuppression, chronic renal failure, congestive heart failure, liver failure) • Children with a history of allergy to cow´s milk or infant formula, eczema, allergic rhinitis or asthma • Children with a family history of eczema, allergic rhinitis, asthma, or milk intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Number of episodes instead of the total number of days with diarrhea, because if the patient requires a specific intervention such as antibiotics for dysentery, it would be unethical to stop the therapy Measure:Number of episodes of diarrhea during the 6-month period. Timepoints:6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:z scores, because they allow comparing weight and height gains between children of different ages. Measure:Determination of growth by measuring z-scores of weight for height Timepoints:6 months | — |
Countries
Peru
Contacts
Public ContactElsa Chea
UNIVERSIDAD PERUANA CAYETANO HEREDIA
Outcome results
None listed