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New treatment option for Food Allergy
Official title Randomized Controlled Trial of Slow Multiallergen Oral Immunotherapy in Young Children
ClinicalTrials.gov ID: NCT06533462
What this study is testing
- What it's testing
- The aim is to study whether a multiallergen oral immunotherapy (OIT) strategy with slow up-dosing and low treatment dose against food allergy in young children (0.5-3 years) is safe and effective, a method to cure food allergy and to prevent the development of new food allergies. Clinical randomized controlled (1:1) blinded interventional trial (RCT) with 2 intervention arms (group A and B).
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
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 3
You may be able to join if
- 0.5-3 years old at inclusion with IgE (\>0.1 kUA/l) against at least one allergen (wheat, lentils, egg, milk, soy, walnut, hazelnut, peanut, almond...
- Written consent for participation in the study for both guardians.
- 80 children (group A and B) also need a positive baseline food challenge.
- Children with a negative food challenge (group C and D) (number not determined) do not react at the baseline challenge.
You likely can't join if
- other serious illness
- previous life-threatening anaphylaxis (intensive care)
- eosinophilic esophagitis
- eosinophilic gastrointestinal disease
- severe chronic gastroesophageal reflux disease
- unclear recurrent GI complaints
See the full eligibility criteria
- 0.5-3 years old at inclusion with IgE (\>0.1 kUA/l) against at least one allergen (wheat, lentils, egg, milk, soy, walnut, hazelnut, peanut, almond, cashew).
- Written consent for participation in the study for both guardians.
- 80 children (group A and B) also need a positive baseline food challenge.
- Children with a negative food challenge (group C and D) (number not determined) do not react at the baseline challenge.
- other serious illness
- previous life-threatening anaphylaxis (intensive care)
- eosinophilic esophagitis
- eosinophilic gastrointestinal disease
- severe chronic gastroesophageal reflux disease
- unclear recurrent GI complaints
- low body weight \<2SD
- participation in another intervention study if included in intervention group
- severe uncontrolled asthma
- medication with biological drugs or oral steroids.
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Sweden
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 months to 3 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Sweden. 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.