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New treatment option for Food Allergy in Children
Official title Comparison Between a Rush and a Conventional Oral Immunotherapy Protocol to Treat Cow's Milk and Hen´s Egg Allergy. CompITO Study
ClinicalTrials.gov ID: NCT06976775
What this study is testing
What is "Rush" regimen?
"Rush" regimen is an investigational medicine, given as an once-daily 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
- This study investigates the efficacy and safety of two different OIT schemes to treat milk and egg allergic children
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 16
You may be able to join if
- Patients 6 to 16 years old
- sIgE levels to milk 0.35 to 35kUA/L for milk allergic people and egg 0.35 to 35kUA/L for egg allergic people
- 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...
- Having a mild to moderate food allergy severity per DEFASE score (\<13 points)
You likely can't join if
- sIgE levels to milk \>35kUA/L for milk allergic people and egg \> 35kUA/L for milk allergic people
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- 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, 6 years to 16 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.