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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT05178004
Eligibility Criteria:
Inclusion criteria
* Infants ≤4 months (prior to weaning)
* Infants born at term (≥37and ≤42weeks), by uncomplicated normal birth or caesarean section and appropriately grown for gestational age.
Exclusion criteria for study population and controls
* Infants who present with pre-existing risk factors for altered intestinal perfusion, among others intrauterine growth restriction, birth asphyxia, exchange transfusion, cyanotic congenital heart disease or polycythemia as these infants are at increased risk of necrotizing enterocolitis.
* Other congenital malformations (chest and abdomen) and infections (such as HIV, hepatitis B and C)
* Those who received antibiotics or need endotracheal, feeding or suctioning tubes will also be excluded as these manipulations could result in modification of microbial flora and could have an impact in intestinal development.
* Participants whose parents/carers cannot speak or understand English will be excluded from the study.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
16 Weeks
Study:
NCT05178004
Study Brief:
Protocol Section:
NCT05178004