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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT02215304
Eligibility Criteria:
Inclusion Criteria:
* Healthy term infants between 3-12 months old
* Written informed consent from at least one parent or the legal tutor.
Exclusion Criteria:
* Short bowel syndrome or any GI surgery.
* Impaired intestinal epithelial barrier (e.g. diarrheal illness, intestinal inflammation).
* Metabolic disorders (diabetes, lactose intolerance).
* Immunodeficiency.
* Heart failure and cardiac medical history (e.g. artificial heart valve, medical history of infectious endocarditis, cardiac malformation, rheumatic fever).
* Surgery within one month prior to inclusion (Visit 1/ week 0).
* Antibiotic prescription 1 week before inclusion (Visit 1/ week 0) and during run-in period (Visit 2/ week 2).
* Investigator's uncertainty about the willingness or ability of the infant's parents to comply with the protocol requirements.
* Participation in any other clinical trial within two weeks prior to entry into the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
12 Months
Study:
NCT02215304
Study Brief:
Protocol Section:
NCT02215304