NCT06976775 Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen´s Egg Allergy. CompITO Study
| NCT ID | NCT06976775 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Pablo Rodríguez del Rio |
| Condition | Food Allergy in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-06-03 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 40 participants in total. It began in 2025-06-03 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children
Eligibility Criteria
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
Contact & Investigator
Dr. Pablo Rodriguez del Río, MD, PhD
PRINCIPAL INVESTIGATOR
Hospital Infantil Niño Jesús, Instituto de Investigación La Princesa
Frequently Asked Questions
Who can join the NCT06976775 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 16 Years, studying Food Allergy in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06976775 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06976775 currently recruiting?
Yes, NCT06976775 is actively recruiting participants. Contact the research team at prrio@yahoo.es for enrollment information.
Where is the NCT06976775 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06976775 clinical trial?
NCT06976775 is sponsored by Pablo Rodríguez del Rio. The principal investigator is Dr. Pablo Rodriguez del Río, MD, PhD at Hospital Infantil Niño Jesús, Instituto de Investigación La Princesa. The trial plans to enroll 40 participants.