PACTR202108480098476RecruitingPhase 3
actoferrin and lysozyme supplementation for long-term diarrhea sequelae
ational Institute of Health0 sites600 target enrollmentStarted: August 25, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 1 Month(s) to 23 Month(s) (—)
- Sex
- All
Inclusion Criteria
- •An eligible child will be aged 6-24 months
- •Child is seen as an inpatient or outpatient for diarrhea who is ready to return home, with a MUAC <12.5 cm at the time of screening
- •Child's caregiver consents for study participation
- •Caregiver plan to remain in study area with the child for at least 6 months
- •Child is not enrolled in another study
- •Child is no longer exclusively breastfeeding
Exclusion Criteria
- •Children younger than 6 months or older than 24 months
- •Accompanying caregiver does not provide consent to study participation
- •Caregiver reports the child will not stay within the study area for the next 6 months
- •Child is enrolled in another study
- •Child is exclusively breastfeeding at the time of enrolment
- •Child is not yet discharged or discharged against medical advice
- •Child has a history of congenital defect or syndrome that prevents age-appropriate feeding (e.g. cleft palate)
- •Unwilling to participate in the dual sugar permeability sub-study if selected
- •History of allergic reaction to dairy products
Investigators
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