actolyze study
- Conditions
- Diarrhea and Malnutrition
- Registration Number
- PACTR202108480098476
- Lead Sponsor
- ational Institute of Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 600
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of medically attended diarrhea;Nutritional recovery;Hospitalization or death;Acceptability ;Adherence;Incremental costs and cost-per-episode of diarrhea averted in each investigational product arm, compared with placebo;Growth;Hemoglobin concentration;Concentrations of specific markers of enteric function (fecal alpha antitrypsin (mg/g), myeloperoxidase (ng/mL), neopterin (nmol/l)
- Secondary Outcome Measures
Name Time Method Prevalence of enteric infections;lactulose:rhamnose ratio