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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT04277260
Eligibility Criteria:
Inclusion Criteria:
* (1) Be healthy, have no acute or chronic diseases, have no severe complications during pregnancy
* (2) Breastfeeding for more than 6 months and Volunteer to participate in this study (signed informed consent)
* (3) Age of maternal women: 20\~35years
* (4) Breast milk is sufficient, and the amount of milk secreted each time is more than 30ml
* (5) No fatal, important organ system deformities and metabolic defects in neonates
Exclusion Criteria:
* (1) for infants: Rescued to death or hospitalized due to critical illness during the study period
* (2)for lactating mothers: exposure to tobacco and alcohol during lactation, severe postpartum depression and other mental and psychological diseases, obesity (BMI\> 28), use of antibiotics or antimetabolites, mastitis with fever within 7 days before specimen collection (T\> 38.5 ℃),Suspension or termination of breastfeeding in the state of maternal and infant illness
Sex:
ALL
Minimum Age:
7 Days
Maximum Age:
35 Years
Study:
NCT04277260
Study Brief:
Protocol Section:
NCT04277260