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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT03467334
Eligibility Criteria:
Inclusion Criteria:
* Infants from 3 to 12 weeks of age
* Born at least at week 34
* Birth weight equal to or greater than 2000 grams
* Fulfill the criteria of Rome III
* Informed consent signed by parents or guardians
Exclusion Criteria:
* Failure to thrive
* Antibiotic treatment less than 2 weeks before the study or during the study
* Take probiotics as a treatment, different from the one that could contain the powdered infant formula
* Abandon breastfeeding and switch to infant formula
* Failure to comply with the study protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Weeks
Maximum Age:
12 Weeks
Study:
NCT03467334
Study Brief:
Protocol Section:
NCT03467334