Hypoallergenicity of a Hydrolyzed Protein Infant Formula (NCT05731206) | Clinical Trial Compass
SuspendedNot Applicable
Hypoallergenicity of a Hydrolyzed Protein Infant Formula
Stopped: Internal discussions
Italy29 participantsStarted 2024-07-31
Plain-language summary
Study to demonstrate hypoallergenicity of a hydrolysed protein infant formula in a population of children with confirmed cow's milk allergy.
Who can participate
Age range
0 Days – 3 Years
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 aged up to 3 years.
. Diagnosed with cow's milk allergy (or re-confirmed), within two months prior to the study (challenge day #1), by:
. Physician-supervised double-blind oral food challenge; or
. Physician-supervised open oral food challenge that elicited objective immediate allergic reactions; or
. Report of convincing allergic reaction to cow's milk or a milk-containing food product, in conjunction with presence of milk-specific serum Immunoglobuline E (IgE) level \> 0.7 kilounit per liter (U/L) or by skin prick test (wheal size ≥ 3mm).
. Willing to switch to a different hypoallergenic formula
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.
. On elimination diet (commercially available, hypoallergenic infant formula ) and free of clinical symptoms, or with controlled stable symptoms, for at least one week preceding the study (challenge day #1).
. Expected minimal consumption of 144ml of test product/day during the open challenge.
Exclusion criteria
. Infants/children who are more suitable to use AAF as first-line formula, including but not limited to those with high risk of anaphylaxis (prior history of anaphylaxis and currently not using eHF) or severe forms of non-IgE-mediated CMA such as eosinophilic oesophagitis, enteropathies, or Food Protein-Induced Enterocolitis Syndrome (FPIES).
. Diagnosis or known allergy to any of the ingredients in the test product.
. Congenital anomalies which will interfere with oral feeding or gastrointestinal tract, other chronic diseases (including but not limited to cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological and endocrine disease), major gastrointestinal disease/abnormalities, or any other medical condition that could interfere with the identification of allergic reactions.
. (Twin / triplet) sibling of an infant/child already participating in the study.
. Investigator's uncertainty about the willingness or ability of the subject and his/her 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.
. Employees and/or children/family members or relatives of employees of Nutricia Research or the participating study sites.