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 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT05046418
Eligibility Criteria:
Inclusion Criteria:
* Aged \<13 months
* Confirmed or suspected CMA- based on healthcare professional (HCP) judgement
* At baseline, parent(s) must already be exclusively or partially formula feeding their child (with a hypoallergenic or non-hypoallergenic formula) or have already made the decision to start exclusively or partially formula feeding
* Recently prescribed a hypoallergenic formula containing synbiotics
Exclusion Criteria:
* Exclusively breastfed infants
* Primary lactose intolerance
* Enterally fed infants
* Premature infants (born \<37 weeks) with a corrected age of less than 1 month
* Infants with contraindications to the use of hyopallergenic formula containing synbiotics
* Major hepatic or renal dysfunction
* Investigator concern around the ability of family to comply with protocol and requirements of study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Months
Maximum Age:
13 Months
Study:
NCT05046418
Study Brief:
Protocol Section:
NCT05046418