Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and … (NCT06976775) | Clinical Trial Compass
RecruitingPhase 2/3
Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen´s Egg Allergy. CompITO Study
Spain40 participantsStarted 2025-06-03
Plain-language summary
This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children
Who can participate
Age range
6 Years – 16 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:
* Patients 6 to 16 years old
* sIgE levels to milk 0.35 to 35kUA/L for milk allergic subjects and egg 0.35 to 35kUA/L for egg allergic subjects
* Entry DBPCFC discrete milk eliciting dose (ED)≥ 22.2mg of milk protein and discrete egg ED≥18.5mg of egg protein, that are the population-based reference values for the ED20
* Having a mild to moderate food allergy severity per DEFASE score (\<13 points)
Exclusion Criteria:
* sIgE levels to milk \>35kUA/L for milk allergic subjects and egg \> 35kUA/L for milk allergic subjects
* Entry DBPCFC discrete milk ED\<22.2mg of milk protein or discrete egg ED\<18.5mg of egg protein
* Entry DBPCFC discrete ED for milk\>2112mg of milk protein (cumulative amount of 4193,7mg of milk protein) and egg discrete ED\>1560mg of egg protein (cumulative amount of 3110.8mg of egg protein)
* Having severe food allergy per DEFASE score (≥13 points)
* Other exclusion criteria: uncontrolled asthma, FEV1\<70%, severe atopic dermatitis, Eosinophilic Esophagitis, non-IgE mediated allergy, having started SCIT 3 months before, or SLIT one week before. Pregnancy
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 adverse events with an oFASS5 severity ≥2 occurred until Induction Phase (Part 1) completion at the hospital setting per subject in both groups, rush vs conventional
Timeframe: Throughout the Induction Phase (Part 1), 1 week up to 7 months
2
Proportion of subjects completing the Induction Phase (Part 1) in both groups (rush vs conventional) at the end of study (7 months of treatment)