Randomized Controlled Trial of Slow Multiallergen Oral Immunotherapy in Young Children

NCT06533462 | Recruiting

• 1 other identifier: Dnr 2024-03574-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Food Allergy; Oral Immunotherapy for Food Allergy

Outcome Measures

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.

  2 years

Secondary Outcomes (7)

• Tolerance to cumulative dose of 900 mg protein at a food challenge after 1 year

  1 year

• Oral brush samples

  1 and 2 years

• Intestinal microbiome

  1 and 2 years

• Immunological biomarkers

  1 and 2 years

• Changes in eczema status in relation to interventions

  1 and 2 years

Study Arms (4)

Group A: Allergic children - Multiallergen OIT

ACTIVE COMPARATOR

Children with food allergy receiving multiallergen powder OIT. Multiallergen food challenge is done before randomization and one and two years after inclusion. OIT multiallergen powder with slow up-dosing until 3 teaspoons of the multiallergen powder is reached and taken daily. 2 years treatment. Number = 40 patients Intervention: multiallergen powder

Dietary Supplement: Multiallergen powder

Group B: Allergic children - Placebo powder

NO INTERVENTION

Children with food allergy receiving OIT with placebo powder (gluten-free oatmeal). Multiallergen food challenge is done before randomization and one and two years after inclusion. Number = 40 patients

Group C: Non-allergic children - low dose multiallergen powder

ACTIVE COMPARATOR

Children not reacting to the baseline challenge who will be randomized to eat a low dose of the multiallergen powder, 1 teaspoon daily. Multiallergen food challenge is done before randomization and one year after inclusion. 1 year treatment. Number = X Intervention: Multiallergen powder

Dietary Supplement: Multiallergen powder

Group D: Non-allergic children - placebo powder

NO INTERVENTION

Children not reacting to the baseline challenge who will be randomized to eat placebo powder (gluten-free oatmeal) and no specific advice. Number= X

Interventions

Multiallergen powder DIETARY_SUPPLEMENT

OIT multiallergen powder.

Group A: Allergic children - Multiallergen OIT; Group C: Non-allergic children - low dose multiallergen powder

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written consent for participation in the study for both guardians.
• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Södersjukhuset

Stockholm, 11883, Sweden

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Caroline Nilsson, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Anna Asarnoj, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Idun Holmdahl, MD, PhD

CONTACT

+46703002279; idun.holmdahl@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study is blinded and neither participants nor the study team physicians know who is receiving multiallergen powder or placebo. Only few persons outside the study has this knowledge.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician, Postdoctoral researcher

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: August 1, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)