Randomized Controlled Trial of Slow Multiallergen Oral Immunotherapy in Young Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-3
SponsorKarolinska Institutet
About this trial
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).
Among 80 children reacting at the multiallergen food challenge, 40 children will be randomized to receive OIT (oral immunotherapy) with multiallergen powder with a final dose of approximately 200 mg protein of each included food (egg, milk, soy, wheat, walnut, peanut, hazelnut, cashew, almond, lentils)(group A) or to receive placebo powder (gluten-free oatmeal) (group B).
A sub-analysis will be performed of the children not reacting to the baseline challenge, who will be randomized to eat a low dose of the multiallergen powder (group C) or placebo powder (gluten-free oatmeal) (group D) and no specific advice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
other serious illness
previous life-threatening anaphylaxis (intensive care)
eosinophilic esophagitis
eosinophilic gastrointestinal disease
Trial design
Design model
Parallel
Treatments tested in this trial
Multiallergen powder
Dietary supplementOIT multiallergen powder.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Group A: Allergic children - Multiallergen OITActive comparator 1 intervention
Group B: Group B: Allergic children - Placebo powderNo intervention 0 interventions
Group C: Group C: Non-allergic children - low dose multiallergen powderActive comparator 1 intervention
Group D: Group D: Non-allergic children - placebo powderNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Tolerance to 900 mg protein at a food challenge after 2 years
Tolerance to 900 mg protein, cumulative dose, of each of the 10 included allergens (in the multiallergen powder), evaluated at a food challenge after 2 years in group A and B. Tolerance is defined as no objective sign of an allergic symptom (urticaria, flush, swelling/angioedema, nasal symptoms, eye symptoms, hoarseness, muffled speech, persistent cough, wheezing, stridor, persistent abdominal pain, severe nausea, vomiting, diarrhea, general impact, drop in blood pressure, decreased oxygenation saturation) within 2 hours after the last dose during the food challenge after 2 years of OIT/placebo.
Time frame
2 yearsSecondary outcomes
1
Tolerance to cumulative dose of 900 mg protein at a food challenge after 1 year
Tolerance to cumulative dose of 900 mg protein of each of the 10 included allergens in the multiallergen powder, evaluated at a food challenge after one year in all children (A, B, C, D). Tolerance is defined as no objective sign of an allergic symptom (urticaria, flush, swelling/angioedema, nasal symptoms, eye symptoms, hoarseness, muffled speech, persistent cough, wheezing, stridor, persistent abdominal pain, severe nausea, vomiting, diarrhea, general impact, drop in blood pressure, decreased oxygenation saturation) within 2 hours after the last dose during the food challenge after one year.
Time frame
1 year2
Oral brush samples
The oral microbiome will be investigated with sequencing-based methods to monitor possible changes in the oral microbiota composition and function related to OIT treatment. Comparisons will be made between intervention groups and analyzed in relation to intervention. Oral brush samples will be collected in connection with the visit for the baseline challenge, at the challenge at 1 years (group A-D) and 2 years (group A-B).
Time frame
1 and 2 years3
Intestinal microbiome
The gut microbiome will be investigated with sequencing-based methods to monitor possible changes in the gut microbiota composition and function related to OIT treatment. Comparisons will be made between intervention groups and analyzed in relation to intervention. Fecal samples will be collected in connection with the visit for the baseline challenge, at the challenge at 1 years (group A-D) and 2 years (group A-B).
Time frame
1 and 2 years4
Immunological biomarkers
To study different immunological biomarkers (e.g. T-helper cell population and polarization and IgE-levels) before, during and after OIT treatment and compare this to the placebo group. Immunological marker in mononuclear cells in peripheral blood will be analyzed ex vivo with flowcytometri and RNA-sequencing platforms. Circulating immunological factors, e.g. cytokines and chemokines will be analyzed in plasma with ELISA-based methods. Mononuclear cellpopulations in peripheral blood will be exposed to different stimuli (such as sensitizing allergen, anti-C D3/ C D28) in vitro, type and level of reaction in the different cellpopulations will be monitored at mRNA- and protein-level. Blood sampling will be collected in connection with the visit for the baseline challenge, at the challenge at 1 years (group A-D) and 2 years (A-B).
Time frame
1 and 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov