Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen´s Egg Allergy. CompITO Study

NCT06976775 | Recruiting Phase 2

• 1 other identifier: compITO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children

Conditions

Food Allergy in Children; Milk Allergy; Egg Allergy

Keywords

Food immunotherapy; Allergy; Milk; Egg; Oral immunotherapy; Anaphylaxis; Mast cell activation test; Saliva; Blood; IgE; Food allergy; Sensitization; Children; Pediatric

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  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

  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

  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)

  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

  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).

  End of study (7 months of treatment)

Study Arms (2)

Rush protocol

EXPERIMENTAL

Milk and egg allergic children undergoing OIT following a Rush regimen

Biological: "Rush" regimen

Conventional protocol

ACTIVE COMPARATOR

Milk and egg allergic children undergoing OIT following a Conventional regimen

Biological: "Conventional" regimen

Interventions

"Conventional" regimen BIOLOGICAL

The "conventional" regimen consists of the administration of only one incremental dose every 2 weeks, throughout all the Induction Phase (Part 1)

Conventional protocol

"Rush" regimen BIOLOGICAL

The "rush" regimen consists of the administration of several incremental doses daily, every day, over the first week of the Induction Phase (Part 1)

Rush protocol

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pablo Rodríguez del Rio: lead

Study Sites (1)

Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65

Madrid, 28009, Spain

RECRUITING

Related Publications (1)

• 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. 2025 Oct 30. doi: 10.1111/cea.70168. Online ahead of print. No abstract available.

  PMID: 41168926 RESULT

MeSH Terms

Conditions

Milk Hypersensitivity; Egg Hypersensitivity; Hypersensitivity; Anaphylaxis; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Dr. Pablo Rodriguez del Río, MD, PhD

  Hospital Infantil Niño Jesús, Instituto de Investigación La Princesa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Pablo Rodríguez del Río

CONTACT

+34915035900; prrio@yahoo.es

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 16, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 18, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)