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 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT05393934
Eligibility Criteria:
Inclusion Criteria:
* Weight faltering babies (weight increments below percentile 15th of weight increments table WHO age 6-12 month-old with good nutritional or mild undernutrition status
* Have a growth chart monitoring (weight, length and head circumference) at least one time (at birth).
* Have the data of height and weight from father and mother (genetic height potential)
* No major congenital anomaly, severely stunted at birth, not having thyroid problem, not suffered from prominent gastrointestinal diseases, severe diseases at the time of inclusion (severe pneumonia, severe dehydration, etc)
* Not suffered from parasitic manifestation by examining the faecel sample at the time of recruitment
* Parents want to follow the study by signing the informed consent
Exclusion Criteria:
* Subjects with stunting
* Subject in the severe disease condition at the time of recruitment
* Severe acute malnutrition
* Parents do not want to participate in the study
* Presence of cow's milk allergy
* Presence of lactose intolerance
* Presence of galactosemia
* Condition needing a special diet, like major renal and hepatic dysfunction
* Have conditions that will influence the nutritional status such as moderate to severe dehydration, organomegaly, oedema.
* Babies with weight more than ideal body weight
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
12 Months
Study:
NCT05393934
Study Brief:
Protocol Section:
NCT05393934