Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533462
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Infant Food Allergen Oral Immunotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Infant Food Allergen Oral Immunotherapy InFO
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
InFO
Brief Summary:
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 05-3 years is safe and effective a method to cure food allergy and to prevent the development of new food allergies
Clinical randomized controlled 11 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 lentilsgroup 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
Clinical randomized controlled 11 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 lentilsgroup 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
Detailed Description:
Today there is no established curative treatment for food allergies and those affected must avoid the food that triggers symptoms The most studied method is oral immunotherapy OIT which have mainly been carried out on children 4 years of age The OIT method implies that the allergic individual eats initially very low doses and gradually increasing amounts of the allergen until a maintenance dose is reached The treatment aims to induce desensitization or tolerance to the allergen
Intervention The intervention substance is a powder containing a prespecified amount of 10 allergens egg milk wheat lentils soy walnut peanut hazelnut cashew almond which are the most triggering allergens in children The product is developed in cooperation with Research Institute of Sweden RISE
Clinical randomized controlled 11 blinded interventional trial RCT with 2 interventions arms group A and B A sub-analysis will be performed of the children not reacting to the baseline challenge group C and D
Group A Children with food allergy sensitization and positive baseline challenge receiving multiallergen powder OIT slow up-dosing until 3 teaspoons of the multiallergen powder is reached daily Food challenge will be performed after 1 and 2 years 2 years treatment
Group B Children with food allergy sensitization and positive baseline challenge receiving OIT with placebo gluten-free oatmeal followed by maintenance in total 2 years Food challenge will be performed after 1 and 2 years
Group C and D sensitized children with a negative baseline challenge will be randomized 11 for treatment with multiallergen powder or placebo powder in a lower amount 1 teaspoon daily and can introduce food in accordance with Swedish guidelines After one year a food challenge will be performed
Selection for group A to D All children 05-3 years of age in Stockholm County who had a positive blood test for suspected food allergy to one or more of the 10 included allergens with specific immunoglobulin E IgE 01 kUAL are eligible as possible study participants The data is obtained from the Karolinska University Laboratorys test results register Information letters will be sent to families with IgE-sensitized children
Inclusion groups A to D Children 05-3 years old at inclusion with positive IgE 01 kUAL against at least one of the 10 above mentioned allergens Eighty children group A n40 and group B n40 also need a positive baseline food challenge
Children with a negative food challenge group C and D number is not determined do not react at the baseline challenge
Primary outcome Tolerance to 900 mg protein cumulative dose of each of the 10 included allergens at the food challenge after two years OIT treatment or placebo group A and B
Secondary outcomes Tolerance to cumulative dose of 900 mg protein of each food evaluated with a food challenge after one years in all children group A-D Changes in immunological markers eczema and asthma status and changes in quality of life in relation to interventions
Intervention The intervention substance is a powder containing a prespecified amount of 10 allergens egg milk wheat lentils soy walnut peanut hazelnut cashew almond which are the most triggering allergens in children The product is developed in cooperation with Research Institute of Sweden RISE
Clinical randomized controlled 11 blinded interventional trial RCT with 2 interventions arms group A and B A sub-analysis will be performed of the children not reacting to the baseline challenge group C and D
Group A Children with food allergy sensitization and positive baseline challenge receiving multiallergen powder OIT slow up-dosing until 3 teaspoons of the multiallergen powder is reached daily Food challenge will be performed after 1 and 2 years 2 years treatment
Group B Children with food allergy sensitization and positive baseline challenge receiving OIT with placebo gluten-free oatmeal followed by maintenance in total 2 years Food challenge will be performed after 1 and 2 years
Group C and D sensitized children with a negative baseline challenge will be randomized 11 for treatment with multiallergen powder or placebo powder in a lower amount 1 teaspoon daily and can introduce food in accordance with Swedish guidelines After one year a food challenge will be performed
Selection for group A to D All children 05-3 years of age in Stockholm County who had a positive blood test for suspected food allergy to one or more of the 10 included allergens with specific immunoglobulin E IgE 01 kUAL are eligible as possible study participants The data is obtained from the Karolinska University Laboratorys test results register Information letters will be sent to families with IgE-sensitized children
Inclusion groups A to D Children 05-3 years old at inclusion with positive IgE 01 kUAL against at least one of the 10 above mentioned allergens Eighty children group A n40 and group B n40 also need a positive baseline food challenge
Children with a negative food challenge group C and D number is not determined do not react at the baseline challenge
Primary outcome Tolerance to 900 mg protein cumulative dose of each of the 10 included allergens at the food challenge after two years OIT treatment or placebo group A and B
Secondary outcomes Tolerance to cumulative dose of 900 mg protein of each food evaluated with a food challenge after one years in all children group A-D Changes in immunological markers eczema and asthma status and changes in quality of life in relation to interventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None