Hypoallergenicity of a New Formula in Subjects With Cow's Milk Allergy (NCT06134466) | Clinical Trial Compass
CompletedNot Applicable
Hypoallergenicity of a New Formula in Subjects With Cow's Milk Allergy
Italy29 participantsStarted 2024-02-13
Plain-language summary
Cow's milk protein allergy (CMA) is an immune-mediated reaction which can either be antibody-driven (IgE-mediated) or cell-mediated (non-IgE-mediated) or mixed, and elicits reactions which are reproducible upon re-exposure to cow's milk proteins. Estimates of CMA prevalence depend on the diagnosis procedure used; recently, a meta-analysis stated an overall pooled estimate for 0-1 year old infants of point prevalence of CMA reported by parents of 4.2% (95 % confidence interval (CI): 3.2-5.4), decreasing to 2.0% (1.5-2.5) when CMA was proven with a double-blind placebo-controlled food challenge (DBPCFC).
CMA manifests through diverse and non-specific symptoms, rendering the CMA diagnosis very difficult. CMA symptoms mainly concern the cutaneous area, the respiratory and gastrointestinal tracts but can also be general. The DBPCFC is therefore considered as the gold standard for the CMA diagnosis.
CMA management consists in the elimination of any source of non-hydrolyzed cow' milk protein from the diet, which is mainly achieved in children by using extensively hydrolyzed formulae (eHFs). As the molecular weight profile of a given hydrolysate cannot predict potential reaction in a given child, the American Academy of Pediatrics recommended that tolerance/hypoallergenicity of any formula intended for children with CMA should be clinically tested in that specific population.
The purpose of this study is to demonstrate the hypoallergenicity of a new liquid hydrolyzed casein-based formula (Investigational Formula) in the management of infants and children with CMA.
Who can participate
Age range
6 Months – 36 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Infants and children between 6 and 36 months of age
* Gestational age ≥ 37 weeks
* Diagnosis of CMA confirmed through a DBPCFC performed within 3 months prior to the enrolment
* Stable clinical condition and free from any symptoms possibly related to CMA for at least four weeks prior to study enrollment
* Observing a strict cow's milk elimination diet for at least 4 weeks prior to study enrollment and until the completion of the study
* Parent(s) or legal guardian agrees not to enroll infant or child in another interventional clinical study while participating in this study
* Written informed consent obtained from at least one parent (or legally acceptable representative \[LAR\], if applicable)
* Infant or child's parent(s) / LAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol
Exclusion Criteria:
* History of anaphylaxis to milk
* Infant is exclusively breastfed
* Any chronic diseases (except mild-moderate atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria).
* Major gastrointestinal disease/abnormalities (other than CMA).
* Other allergies.
* Immunodeficiency.
* Antihistamine use (excluding eye drops) within 7 days prior to the food challenge or oral steroid use within 14 days prior to the food challenge.
* Persistent whe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of IgE-mediated cow's milk allergy subjects with negative of oral food challenge for the new investigational extensively casein formula
Timeframe: Through study completion, an average up tp 50 days