Oral immunotherapy versus natural course for milk and egg allergy in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 1/2 study compares children managed with natural evolution to children who undergo oral immunotherapy (OIT) to characterize tolerance outcomes and underlying immune mechanisms. Eligible children are 4–10 years old with confirmed milk and/or egg allergy by positive open food challenge and specified sIgE ranges, while the OIT cohort includes participants from the companion compITO study who achieved partial or full desensitization by month 7. Outcomes include tolerance measured by food challenge (oFASS5 classification) and immunologic biomarkers to map mechanisms of desensitization or persistence. The trial is conducted at Hospital Infantil Universitario Niño Jesús in Madrid with standardized challenge and monitoring procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

NAT-cohort:

* Cow´s Milk and/or Hen´s Egg allergic patients 4 to 10 years old
* sIgE levels to milk OR egg extracts between 0.35 to 35kUA/L
* Positive entry Open food challenge with milk/egg with oFASS5 classification ≥2 with a maximum cumulative dose of up to 4193.7 mg of milk protein or 3110.8 mg of egg white protein
* Having a mild to moderate food allergy severity per the Definition of Food Allergy Severity (DEFASE) score (\<13 points)
* Having signed the informed consent

OIT-cohort:

* Patients in the compITO study (NCT06976775) who are undergoing OIT and have achieved full desensitization to the food by month 7 of the study (end of study)
* Patients in the compITO study who are undergoing OIT and have achieved partial desensitization (tolerating a dose lower than the total dose, and a minimum of 3 doses above the entry challenge threshold) to the food by month 7 of the study (end of study)
* Having signed the informed consent

Exclusion Criteria:

NAT-cohort:

* Positive reaction in the entry open oral food challenge with a baseline Eliciting Dose (ED) 20 below the target ED20 for food. For milk, 23.1 mg (35.7 mg cumulative) of protein, or for egg, 19.5 mg (29.4 mg cumulative) of protein.
* Patient desire or medical indication to initiate OIT at any time within 29 months of study entry.
* No allergic reaction greater than oFASS5 grade 1 in the baseline challenge for the maximum cumulative programmed doses of 4193.7 mg of milk protein, or 3110.8 mg of egg white protein.
* Immunological diseases, immunomodulatory/blocking therapies.
* Severe atopic dermatitis according to the SCORing Atopic Dermatitis (SCORAD) classification
* Severe allergy, according to a DEFASE score ≥13
* Spirometry values with moderate-to-severe airflow obstruction (FEV1 \<70%)
* Poorly controlled asthma according to clinical criteria
* Previous OIT for another food
* Within the first 3 months of treatment with Subcutaneous Aeroallergen Immunotherapy
* Within the first week of treatment with Sublingual Aeroallergen Immunotherapy
* Presence or suspicion of Eosinophilic Esophagitis
* Non-IgE-mediated allergy to milk or egg
* Pregnancy
* Significant medical comorbidities (renal, hepatic, or cardiac insufficiency, active infectious diseases, previous or concurrent cancers)
* Inability to provide informed consent
* Communication or cognitive barriers that prevent adherence to the protocol

OIT-cohort:

* Patients enrolled in the compITO study who have failed or withdrawn from the study for any reason.
* Patients with uncontrolled Atopic Dermatitis or Asthma at the time of enrolment, or who have developed Eosinophilic Esophagitis.
* Patients with confirmed pregnancy at the time of enrolment.
* Patients who have developed significant medical comorbidities (renal, hepatic, or cardiac insufficiency, active infectious diseases, previous or concurrent cancers) at the time of enrolment.
* Inability to provide informed consent.
* Communication or cognitive barriers that prevent adherence to the protocol.

Where it's running

• Hospital Infantil Universitario Niño Jesús. Avenida de Menéndez Pelayo, número 65
  Madrid, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Pablo Rodríguez del Río, MD PhD
• Email: prrio@yahoo.es
• Phone: +34915035900

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Peanut Oral Immunotherapy for Children in Hong Kong

  This study tests whether peanut oral immunotherapy can desensitize children under 18 with peanut allergy in real-world Hong Kong settings compared with standard peanut avoidance.

  Recruiting Chinese University of Hong Kong · Hong Kong · NCT07592780

• Nickel and LTP sensitization in children with functional gastrointestinal disorders

  This research tests whether sensitization to non-specific lipid transfer proteins (LTPs) and to nickel is linked to functional gut symptoms in children aged 4 and older with dyspepsia or irritable bowel symptoms.

  Recruiting Federico II University · Naples, Naples · NCT07105865

• Rush versus conventional oral immunotherapy for cow's milk and hen's egg allergy in children

  This test compares a faster 'rush' oral immunotherapy schedule with a conventional slower schedule to see which better helps children aged 6–16 with milk or egg allergy tolerate those foods.

  Recruiting Phase 2/3 Fundación de Investigación Biomédica - Hospital Universitario de La Princesa · Madrid · NCT06976775

• Evaluating Omalizumab's Effect on Skin in Food Allergy Patients

  This study is testing if the medication omalizumab can improve skin problems in people with food allergies and help reduce their allergic reactions.

  Recruiting Phase 4 National Jewish Health · Denver, Colorado · NCT06618963

• Boiled cashew treatment for children with food allergies

  This study is testing if giving boiled cashews to children with cashew allergies can help them safely eat cashews and possibly other tree nuts too.

  Recruiting Phase 2 Chinese University of Hong Kong · Hong Kong · NCT06467994

• Program to help children manage food allergies

  This study is testing a program to help early teens with food allergies and their caregivers learn how to manage allergies better and feel more confident.

  Recruiting Children's National Research Institute · Washington D.C., District of Columbia · NCT06034678

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.