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 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT06366204
Eligibility Criteria:
Inclusion Criteria:
* Healthy
* Female
* 20-40 years
* Had a singleton pregnancy and is breastfeeding a single child.
* Exclusively breastfeeding an infant 3 - 4 months of age OR complimentary. feeding an infant 9-10 months of age.
Exclusion Criteria:
* Participants not in good health or have a history of metabolic, cardiovascular, neurological, genetic, endocrine, immune, or physical mobility disorders.
* Participants that had major pregnancy or delivery complications (e.g., preeclampsia/ eclampsia, placenta previa, postpartum haemorrhage, neonatal intensive care, gestational diabetes).
* Participants with substance dependence issues (e.g., nicotine, alcohol, marijuana, illicit drugs).
* Participants that have had breast surgery that may impact lactation, lactogenesis or breastfeeding.
* Participants that use medications that affect lactation (e.g. estrogenic birth control, anti-dopaminergic drugs, Methyldopa) or other continuous prescription medication.
* Participants with a pre-pregnancy BMI below 18 kg/m² or above 28 kg/m².
* Participants who are below 20 years of age or greater than 40 years of age.
* Infants' weight and length are under 3rd or above the 97th percentile, using the World Health Organization (WHO) percentile growth chart.
* Infants born before 38 weeks or after 42 weeks of gestation.
* Infants who use infant formula milk.
* Infants with known metabolic, cardiovascular, neurological, genetic, endocrine, immune, or physical mobility disorders.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT06366204
Study Brief:
Protocol Section:
NCT06366204