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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT03874104
Eligibility Criteria:
Inclusion Criteria:
* Aged \<13 months
* Currently using or requiring an extensively hydrolysed formula for the dietary management of cows' milk allergy
* Expected to receive at least 25% of their energy intake from the study feed
* Already fed with infant formula or hypoallergenic formula (either partially or fully)
* Written, informed consent from parent/carer
Exclusion Criteria:
* "Severe" cows' milk allergy (clinically judged to require an amino acid formula) or any other contraindications to the use of an extensively hydrolysed formula
* Exclusively breastfed infants
* Primary lactose intolerance
* History of poor tolerance to whey based EHFs
* Immunocompromised infants
* Premature infants (born \<37 weeks)
* Major hepatic or renal dysfunction
* Requirement for any parenteral nutrition
* Tube-fed via a post-pyloric route
* Participation in other clinical intervention studies within 1 month of recruitment to this study
* Investigator concern around the ability of family to comply with protocol and requirements of study
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
13 Months
Study:
NCT03874104
Study Brief:
Protocol Section:
NCT03874104