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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT05924633
Eligibility Criteria:
Inclusion Criteria:
* Postpartum women aged 18-49 years
* Multiparous with one previously breastfed child (defined as breastfed for greater than or equal to 3 months, does not need to be exclusively breastfed)
* Delivered term
* Woman free of breast or nipple infections
* Woman willing to avoid other galactagogues/breastmilk supply stimulants while on study
* Woman not taking medications that will affect lactation
* Woman is the established carer for the infant
* Infant has no baseline abnormality.
Exclusion Criteria:
* Less than 18 years old or older than 49 years (at time of recruitment)
* Smokers
* Individuals that are not free-living e.g. institutes where meals are prepared in bulk such as nursing homes, prisons etc.
* An inability to read, write or understand English
* Following a strict prescribed diet for any reason; insulin dependent diabetes, coeliac disease, Crohn's disease etc. as this may result in an altered gastrointestinal function.
* Mother or child has a milk protein allergy
* Covid-19 at very high-risk group (defined by HSE)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT05924633
Study Brief:
Protocol Section:
NCT05924633