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:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT05614505
Eligibility Criteria:
Inclusion Criteria:
* Children with uncomplicated SAM (WHZ \< -3 and/or MUAC \<115 mm) qualified for outpatient treatment, or nutritional edema regardless of anthropometry
* Aged 6-59 months old upon enrolment
* Pass appetite test
* Never received in- and outpatient treatment on SAM (including not having consumed RUTF, F75, F100 or special medical specialty food1 in the last two months
* Willing to participate in the study (parent signed the informed consent)
Exclusion Criteria:
* Body weight \< 4.0 kg;
* Uncontrolled or untreatable systemic opportunistic infection, such as active TB, HIV;
* Obvious dysmorphic features, general mental health problems (e.g., Down syndrome, etc.), other conditions interfering with normal growth;
* Participating in another clinical trial;
* Any congenital disorder that interferes with normal nutrient intake; chronic conditions including but not exclusively disorders of heart, kidney or liver (children to be screened by a physician);
* SAM with complications requiring hospital treatment (including edema +3);
* Severe anemia (Hb\<7g/dL);
* Is a twin or multiple;
* Allergy to milk, nuts, legumes and/or antibiotics (Amoxicillin and Ampicillin)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
59 Months
Study:
NCT05614505
Study Brief:
Protocol Section:
NCT05614505