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New treatment option for Food Allergy in Children
Official title Tolerance Results and Immune Mechanisms in Cow´s Milk and/or Hen´s Egg Allergic Children Following Natural Evolution or Oral Immunotherapy
ClinicalTrials.gov ID: NCT07419243
What this study is testing
What is Oral Immunotherapy?
Oral Immunotherapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for food allergy in children.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Allergy to Cow's milk and hen´s egg proteins are the most common causes of food allergies in early childhood and are associated with the occurrence of adverse events that may be life-threatening, quality of life impairment and negative nutritional and health economic impact. However, contrarily to other food allergy models such as nuts/peanut allergy, milk and egg allergy have greater chances of natural resolution.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 17
You may be able to join if
- 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...
- Having a mild to moderate food allergy severity per the Definition of Food Allergy Severity (DEFASE) score (\<13 points)
You likely can't join if
- 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...
- 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...
- Immunological diseases, immunomodulatory/blocking therapies.
- Severe atopic dermatitis according to the SCORing Atopic Dermatitis (SCORAD) classification
See the full eligibility 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...
- Having signed the informed consent
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.