Diarrhea and Malnutrition
Conditions
Interventions
Lactoferrin Arm
Lysozyme Arm
Lactoferrin and Lysozyme combination Arm
Placebo Arm
Sponsors
National Institute of Health
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe diarrhea;Time to nutritional recovery | — |
Secondary
| Measure | Time frame |
|---|---|
| Severe diarrhea;Dysentery ;Diarrhea (any severity);Medically-attended diarrhea;Cumulative duration of diarrhea;Incidence of hospitalization;Hemoglobin concentration;Growth;Concentrations of specific markers of enteric function (fecal alpha antitrypsin [mg/g], myeloperoxidase [ng/mL] and calprotectin [mcg/g]);Prevalence of enteric infections;Acceptability;Adherence;Incremental cost-effectiveness | — |
Countries
Kenya
Contacts
Public ContactJoyce Otieno
Study Coordinator
Outcome results
None listed