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 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT05703659
Eligibility Criteria:
NOTE: Age limits listed are for mothers. For infants, age limits are a minimum of 1 day and a maximum of 1 month
Inclusion Criteria:
* Healthy singleton pregnancy, term delivery (\>= 36 weeks corrected gestational age)
* Maternal intent to exclusively breastfeed for the first six months of infant life (intent to breastfeed for six months correlates with longer duration of breastfeeding, this increases the chance that mothers will still be breastfeeding at the end of the study)
* Maternal vaccination against COVID19 (2 doses Pfizer or Moderna and within 6 months of second dose or 2 doses Pfizer or Moderna and booster.) COVID vaccination is required for maternal participation as this is a study meant to enable transmission of beneficial bacteria species between infants, and infants are too young to be vaccinated.
Exclusion Criteria:
* Maternal drug abuse
* Infant congenital abnormalities
* Infant age greater than 1 month at first lactation support group meeting (younger infants will have less developed microbiomes, increasing the chance of successful transmission of bacteria)
* Intent to provide a non-study probiotics to the infant
* Known immunocompromised status of the infant.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
62 Years
Study:
NCT05703659
Study Brief:
Protocol Section:
NCT05703659