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 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT01507935
Eligibility Criteria:
Inclusion Criteria:
* Healthy term infants (gestational age 37 to 42 weeks) aged 2-2.5 months at inclusion
* Fully formula fed for at least one week (not applicable for the breastfeeding reference group since these infants must be exclusively breastfed before and throughout the study)
* Parents' or guardian's written informed consent
Exclusion Criteria:
* Being weaned before inclusion (introduction of any other foods other than formula or breast milk.)
* Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
* Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps)
* Significant congenital abnormality that could affect the study results
* Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks preceding the study
* Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
* Gastroenteritis in the last two weeks before inclusion
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Weeks
Maximum Age:
10 Weeks
Study:
NCT01507935
Study Brief:
Protocol Section:
NCT01507935