Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT06382857
Eligibility Criteria:
Inclusion Criteria:
* for children with Severe Acute Malnutrition (SAM): MUAC \< 115 mm and/or WLZ \< -3 and/or mild (+) or moderate (++) edema
* for children with Moderate Acute Malnutrition (MAM): 115 mm ≤ MUAC \< 125 mm and/or -3 ≤ WHZ \< -2
* Caregiver providing informed consent
Exclusion Criteria:
* Medical complications requiring inpatient treatment, as identified by the national protocol
* Not eating/lack of appetite (as informed by appetite test and investigator judgement)
* Re-admission into the program within 2 months of previous default
* for children with Severe Acute Malnutrition (SAM): Referral from inpatient care (therapeutic feeding center, TFC) or supplementary feeding program (SFP)
* for children with Moderate Acute Malnutrition (MAM): Referral from SAM treatment (TFC or OTP)
* Presence of congenital abnormality or underlying chronic disease that may affect growth or risk of infection
* Known contraindication/ hypersensitivity/allergy to study interventions (chickpea/soy flour, banana, peanut)
* Residence outside the study catchment area or in a non-fixed (e.g. nomadic) community
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
23 Months
Study:
NCT06382857
Study Brief:
Protocol Section:
NCT06382857