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 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT04639232
Eligibility Criteria:
Inclusion Criteria:
1. Lactating women between 18 and 45 years old, who have given birth to a healthy baby at term (born between 37 and 42 weeks).
2. Who have the perception of having little volume of milk or a nutritional composition of milk that is not adequate for their baby
3. That they are between week 2 and week 6 of breastfeeding, and that at the time of beginning the study they are not supplementing with formula milk the feeding of their baby.
4. That they have the firm intention of breastfeeding for 28 more days.
5. Women who agree to participate and have read, understood and signed the informed consent
Exclusion Criteria:
1. Suffering from any disease that may hinder or prevent breastfeeding
2. Being currently consuming or having consumed in the two weeks prior to the study a probiotic or a supplement with plant extracts.
3. Being consuming any drug that can alter the volume or composition of breast milk.
4. Have an allergy to any antibiotics or peanuts
5. Have an allergy to any of the components of the products under study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04639232
Study Brief:
Protocol Section:
NCT04639232