RANDOMIZED, CONTROLLED LACTOFERRINE STUDY FOR THE PREVENTION OF DIARRHEA IN CHILDRE

Not Applicable

• Conditions: -A09 Diarrhoea and gastroenteritis of presumed infectious origin; Diarrhoea and gastroenteritis of presumed infectious origin; A09

• Registration Number: PER-095-07
• Lead Sponsor: ATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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<br>Measure:Number of episodes of diarrhea during the 6-month period.<br>Timepoints:6 months<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:z scores, because they allow comparing weight and height gains between children of different ages.<br>Measure:Determination of growth by measuring z-scores of weight for height<br>Timepoints:6 months<br>