Food Allergy in ChildrenPhase 2/3compITONCT06976775
Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen´s Egg Allergy. CompITO Study
A Phase 2/3 study testing "Rush" regimen and "Conventional" regimen in people with Food Allergy in Children and Milk Allergy, run by Pablo Rodríguez del Rio at 1 site in Spain.
Trial summary
This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Food Allergy in Children, Milk Allergy, Egg Allergy
- What is being tested?
- "Rush" regimen and "Conventional" regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jun 2025to 30 Apr 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65
Madrid, 28009
Dr. Pablo Rodríguez del Río, +34915035900, prrio@yahoo.es
About this study
Official title: Comparative Analysis Between Two Oral Immunotherapy Schemes in Cow´s Milk and/or Hen´s Egg Allergic Children to Improve Treatment Efficiency and Identify Response Biomarkers. CompITO Study
This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children
Read the detailed description
Food immunotherapy, especially oral immunotherapy (OIT), is now a standard treatment option for patients allergic to cow´s milk, hen´s egg or peanuts. While peanut OIT has drawn considerable attention from the scientific community, milk and hen´s egg OIT still remain as the most common immunotherapy administered in daily routine. Optimization of these treatments is a priority to offer to a wider number of candidates a more efficient and safe way of treatment.
A Phase II/III randomized clinical trial enrolling a total of 40 patients with non-severe food allergies (20 cow's milk allergic children and 20 hen's egg allergic children) to assess the safety and efficacy of a rush/rapid versus a conventional OIT protocol.
Schemes are comparable in terms of the number of doses, the relative increment between doses and the final amount of protein, with one exception: the "rush" regimen includes several doses given the same day over the first week of treatment while in the "conventional" regimen Induction Phase is based upon single doses given every 2 weeks.
There are two different parts in the study, during Induction Phase (Part 1, 1 week up to 7 months), participants in both groups will receive incremental doses of milk/egg, depending on their allergy, until they tolerate 6600 mg or 4680mg of milk or egg protein respectively. The occurrence of adverse events in both groups will result in dose adjustments and delay in completion Induction Phase. During Maintenance Phase (Part 2), patients will ingest the same dose (daily for milk and every 48h for egg) until the end of study, that will last for a total duration of 7 months.
The study features a dual primary outcome. Safety and efficacy variables are primary outcomes, and parents and patient-reported food allergy-related quality of life (HRQoL) are secondary outcomes, as well as burden of treatment and immunological changes. Molecular changes underlying OIT will be studied, and biomarkers of safety and efficacy will be sought
- Conditions
- Food Allergy in Children, Milk Allergy, Egg Allergy
- Being tested
- "Rush" regimen, "Conventional" regimen
- Keywords
- Food immunotherapy, Allergy, Milk, Egg, Oral immunotherapy, Anaphylaxis, Mast cell activation test, Saliva, Blood, IgE, Food allergy, Sensitization, Children, Pediatric
- Medical subject headings
- Milk Hypersensitivity, Egg Hypersensitivity, Hypersensitivity, Anaphylaxis, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Rush" regimenBiological
The "rush" regimen consists of the administration of several incremental doses daily, every day, over the first week of the Induction Phase (Part 1)
"Conventional" regimenBiological
The "conventional" regimen consists of the administration of only one incremental dose every 2 weeks, throughout all the Induction Phase (Part 1)
| Study group | Role | What they receive |
|---|---|---|
| Rush protocol | Experimental | Milk and egg allergic children undergoing OIT following a Rush regimen Receives: Biological: "Rush" regimen |
| Conventional protocol | Active comparator | Milk and egg allergic children undergoing OIT following a Conventional regimen Receives: Biological: "Conventional" regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Throughout the Induction Phase (Part 1), 1 week up to 7 months
Proportion of subjects completing the Induction Phase (Part 1) in both groups (rush vs conventional) at the end of study (7 months of treatment)
Measured: End of study (7 months of treatment)
Secondary outcomes (9)
Number of adverse events with an oFASS5 severity ≥2 reported until Induction Phase (Part 1) completion at home and hospital setting per subject in both groups, rush vs conventional
Measured: Throughout the Induction Phase (Part 1), 1 week up to 7 months
Number of anaphylaxis events reported until Induction Phase (Part 1) completion at home and hospital setting per subject in both groups, rush vs conventional
Measured: Throughout the Induction Phase (Part 1), 1 week up to 7 months
Comparison of the median threshold change between baseline double blind placebo-controlled food challenge (DBPCFC) and maximum tolerated dose (mg of protein) between rush and conventional protocol subjects at the end of the study (7 months of treatment)
Measured: End of study (7 months of treatment)
Comparison of the median number of days needed in both groups, rush vs conventional, to complete the Induction Phase (Part 1) in subjects accomplishing this outcome
Measured: Throughout the Induction Phase (Part 1), 1 week up to 7 months
Comparison of the median Food Allergy Quality of Life Questionnaire, Parental Form (FAQLQ-PF) score change in patients undergoing rush vs conventional protocols between baseline and end of study (7 months of treatment).
FAQLQ-PF values range from 0 to 6, with higher scores representing more QoL impairment
Measured: End of study (7 months of treatment)
Comparison of the median burden of treatment score in patients undergoing rush vs conventional protocols at the end of study (7 months of treatment)
Burden of treatment evaluation will be carried out applying a new tool in current development, where values range from 0 to 6, and with higher scores representing a more burdensome treatment
Measured: End of study (7 months of treatment)
Comparison of the median sIgE levels (kU/L) to milk or egg proteins in patients undergoing rush vs conventional protocols at baseline and at end of study (7 months of treatment)
Measured: End of study (7 months of treatment)
Comparison of the median SPT (mm) wheal size to milk or egg proteins in patients undergoing rush vs conventional protocols at baseline and at end of study (7 months of treatment)
Measured: End of study (7 months of treatment)
Comparison of the median sIgG4 (mg/L) levels to milk or egg proteins in patients undergoing rush vs conventional protocols at baseline and at end of study (7 months of treatment)
Measured: End of study (7 months of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start3 Jun 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pablo Rodríguez del Rio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pablo Rodríguez del Rio, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Investigators
- Dr. Pablo Rodriguez del Río, MD, PhD, Principal investigator, Hospital Infantil Niño Jesús, Instituto de Investigación La Princesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976775
- Sponsor's protocol ID
- compITO
- Acronym
- compITO
- Status last verified
- Jul 2025
- First submitted
- 18 Apr 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eusebio-Cartagena I, Jimenez-Saiz R, Esteban V, Nunez-Borque E, Ruiz-Sanchez A, Escudero C, Sanchez-Garcia S, Trujillo J, Dunn-Galvin A, Ibanez-Sandin MDP, Rodriguez Del Rio P. Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen's Egg Allergy. CompITO Study Methodology. Clin Exp Allergy. 2026 Apr;56(4):421-423. doi: 10.1111/cea.70168. Epub 2025 Oct 30. No abstract available.
PubMed 41168926
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis Between Two Oral Immunotherapy Schemes in Cow´s Milk and/or Hen´s Egg Allergic Children to Improve Treatment Efficiency and Identify Response Biomarkers. CompITO Study
- ClinicalTrials.gov ID
- NCT06976775
- Acronym / sponsor ID
- compITO / compITO
- Conditions
- Food Allergy in Children, Milk Allergy, Egg Allergy
- Keywords
- Food immunotherapy, Allergy, Milk, Egg, Oral immunotherapy, Anaphylaxis, Mast cell activation test, Saliva
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pablo Rodríguez del RioUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children
Detailed description
Food immunotherapy, especially oral immunotherapy (OIT), is now a standard treatment option for patients allergic to cow´s milk, hen´s egg or peanuts. While peanut OIT has drawn considerable attention from the scientific community, milk and hen´s egg OIT still remain as the most common immunotherapy administered in daily routine. Optimization of these treatments is a priority to offer to a wider number of candidates a more efficient and safe way of treatment.
A Phase II/III randomized clinical trial enrolling a total of 40 patients with non-severe food allergies (20 cow's milk allergic children and 20 hen's egg allergic children) to assess the safety and efficacy of a rush/rapid versus a conventional OIT protocol.
Schemes are comparable in terms of the number of doses, the relative increment between doses and the final amount of protein, with one exception: the "rush" regimen includes several doses given the same day over the first week of treatment while in the "conventional" regimen Induction Phase is based upon single doses given every 2 weeks.
There are two different parts in the study, during Induction Phase (Part 1, 1 week up to 7 months), participants in both groups will receive incremental doses of milk/egg, depending on their allergy, until they tolerate 6600 mg or 4680mg of milk or egg protein respectively. The occurrence of adverse events in both groups will result in dose adjustments and delay in completion Induction Phase. During Maintenance Phase (Part 2), patients will ingest the same dose (daily for milk and every 48h for egg) until the end of study, that will last for a total duration of 7 months.
The study features a dual primary outcome. Safety and efficacy variables are primary outcomes, and parents and patient-reported food allergy-related quality of life (HRQoL) are secondary outcomes, as well as burden of treatment and immunological changes. Molecular changes underlying OIT will be studied, and biomarkers of safety and efficacy will be sought
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rush protocol | Experimental | Biological: "Rush" regimenMilk and egg allergic children undergoing OIT following a Rush regimen |
| Conventional protocol | Active comparator | Biological: "Conventional" regimenMilk and egg allergic children undergoing OIT following a Conventional regimen |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Rush" regimenThe "rush" regimen consists of the administration of several incremental doses daily, every day, over the first week of the Induction Phase (Part 1) | Biological | Rush protocol |
| "Conventional" regimenThe "conventional" regimen consists of the administration of only one incremental dose every 2 weeks, throughout all the Induction Phase (Part 1) | Biological | Conventional protocol |
Primary outcome
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
Time frame: Throughout the Induction Phase (Part 1), 1 week up to 7 months
Proportion of subjects completing the Induction Phase (Part 1) in both groups (rush vs conventional) at the end of study (7 months of treatment)
Time frame: End of study (7 months of treatment)
9 secondary outcomes
Number of adverse events with an oFASS5 severity ≥2 reported until Induction Phase (Part 1) completion at home and hospital setting per subject in both groups, rush vs conventional
Time frame: Throughout the Induction Phase (Part 1), 1 week up to 7 months
Number of anaphylaxis events reported until Induction Phase (Part 1) completion at home and hospital setting per subject in both groups, rush vs conventional
Time frame: Throughout the Induction Phase (Part 1), 1 week up to 7 months
Comparison of the median threshold change between baseline double blind placebo-controlled food challenge (DBPCFC) and maximum tolerated dose (mg of protein) between rush and conventional protocol subjects at the end of the study (7 months of treatment)
Time frame: End of study (7 months of treatment)
Comparison of the median number of days needed in both groups, rush vs conventional, to complete the Induction Phase (Part 1) in subjects accomplishing this outcome
Time frame: Throughout the Induction Phase (Part 1), 1 week up to 7 months
Comparison of the median Food Allergy Quality of Life Questionnaire, Parental Form (FAQLQ-PF) score change in patients undergoing rush vs conventional protocols between baseline and end of study (7 months of treatment).
Time frame: End of study (7 months of treatment)
Comparison of the median burden of treatment score in patients undergoing rush vs conventional protocols at the end of study (7 months of treatment)
Time frame: End of study (7 months of treatment)
Comparison of the median sIgE levels (kU/L) to milk or egg proteins in patients undergoing rush vs conventional protocols at baseline and at end of study (7 months of treatment)
Time frame: End of study (7 months of treatment)
Comparison of the median SPT (mm) wheal size to milk or egg proteins in patients undergoing rush vs conventional protocols at baseline and at end of study (7 months of treatment)
Time frame: End of study (7 months of treatment)
Comparison of the median sIgG4 (mg/L) levels to milk or egg proteins in patients undergoing rush vs conventional protocols at baseline and at end of study (7 months of treatment)
Time frame: End of study (7 months of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Results publication: PubMed 41168926Eusebio-Cartagena I, Jimenez-Saiz R, Esteban V, Nunez-Borque E, Ruiz-Sanchez A, Escudero C, Sanchez-Garcia S, Trujillo J, Dunn-Galvin A, Ibanez-Sandin MDP, Rodriguez Del Rio P. Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen's Egg Allergy. CompITO Study Methodology. Clin Exp Allergy. 2026 Apr;56(4):421-423. doi: 10.1111/cea.70168. Epub 2025 Oct 30. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Pablo Rodriguez del Río, MD, PhD principal investigator
Hospital Infantil Niño Jesús, Instituto de Investigación La Princesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing "Rush" regimen and "Conventional" regimen in people with Food Allergy in Children and Milk Allergy, run by Pablo Rodríguez del Rio at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Pablo Rodríguez del Río (+34915035900, prrio@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Throughout the Induction Phase (Part 1), 1 week up to 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06976775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.