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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT05738460
Eligibility Criteria:
Inclusion Criteria:
* Infants:37-41 weeks of age, born through vaginal delivery, 2500g\<= birth weight \< 4000g,0-3 years of age;
* The mother: birth ranging in age from 18 to 40 years old, the single pregnancy, pregnancy 35 -41 weeks to complete the GBS screening;
* The guardian agrees to participate in the study voluntarily.
Exclusion Criteria:
* Infants and children with serious congenital abnormalities, infections or clinical diseases;
* Antibiotics should be used in infants within 2 weeks, probiotics, prebiotics and biostime should be supplemented, or long-term drug treatment should be given for digestive, immune, blood and other diseases;
* Infant mothers: childbirth after long-term drug treatment due to digestive, immune, blood and chronic diseases during pregnancy; Or infants who were breastfed within 12 hours of antibiotic use after delivery;
* Any medical or non-medical condition that the investigator deems inappropriate to participate in.
Sex:
ALL
Minimum Age:
37 Weeks
Maximum Age:
41 Weeks
Study:
NCT05738460
Study Brief:
Protocol Section:
NCT05738460