Swedish Study of Immunotherapy for Milk Allergy in Children

NCT ID: NCT03819556

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-20
• Study Completion Date: 2024-10-20

Brief Summary

This trial is a two-armed open randomized controlled trial in children aged 5-15 years with challenge proven Immunoglobulin E (IgE)-associated milk allergy.The purpose is to determine if oral immunotherapy with milk can induce tolerance to milk. The active intervention is intake of increasing amounts of fresh milk for six months followed by three years of maintenance treatment with milk. The control group continues their elimination (milk free) diet. The trial will recruit patients at ten pediatric departments in Sweden, coordinated by Umeå University. The primary outcome is milk tolerance (defined as a negative double-blind placebo-controlled milk challenge) at trial completion 3.5 years after start of treatment. Secondary outcomes include allergic symptoms during treatment documented as certain allergic manifestations, changes in immunological and microbial biomarkers, quality of life and nutritional status.

Detailed Description

The underlying hypothesis is that exposure to milk in a controlled way can be delivered safely and induce tolerance to milk.The aim of this trial is to evaluate a specific protocol for oral milk intake to achieve sustainable tolerance.

Before randomization all patients are tested for milk allergy using a double-blind placebo-controlled milk challenge and baseline laboratory analyses (specific IgE). Patients with confirmed, challenge-proven milk allergy are randomized to oral immunotherapy (active group) or milk-free diet (control group).The active group will receive a stepwise increase in oral milk intake. The increased dose will be given in hospital outpatient clinics by experienced study staff following a standard protocol. All other doses are given att home where the patients have adrenaline ready to use. When the patient has reached a daily intake of 100 ml of milk without serious allergic reactions they will be maintained on this dosis for three years. At this stage (after finished dose escalation or after six months for the control group) the patients will be tested for the second set of laboratory analyses.

During maintenance, the patients in the active group are encouraged not to avoid milk protein and instead eat milk-containing food when it is offered. Patients in the control group receive standard care with exclusion of milk from their diet for the whole trial duration.

After three years of maintenance therapy for the active group, both groups avoid milk for one week and then undergo a double-blind placebo-controlled milk challenge and the third set of samples for immunological comparison.

The immunological markers are Immunoglobulins (E, G4, A), microbiota and basophilic activation. All patients are also evaluated for quality of life and nutritional status.

Conditions

Milk Allergy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active immunotherapy with milk protein

Daily dose fresh milk protein increased in 11 steps

Group Type: ACTIVE_COMPARATOR

Milk protein in fresh milk

Intervention Type: OTHER

Milk protein in increasing doses.

Control

Diet free from milk protein

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Milk protein in fresh milk

Milk protein in increasing doses.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Immunoglobulin E (IgE) milk >0.1 kU/L
• Allergic reaction within 2 hours after intake of milk protein
• Age 5-15 years

Exclusion Criteria

• Uncontrolled asthma, >12 % increase in Forced Expiratory Volume in 1 second (FEV1) after inhaled bronchodilatator and Asthma Control Test (ACT)<20
• No allergic reaction at a controlled milk challenge
• Cancer
• Severe immune deficiency
• Autoimmune disease
• Chronic urticaria
• Eosinophil esophagitis
• Pregnancy and breastfeeding
• Ongoing immunotherapy to one or more allergens

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Christina West

Associate professor/Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina E West, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Solveig Röisgård

Östersund, Jämtland Härjedalen, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Christina West, Associated professor

Role: CONTACT

christina.west@umu.se

+46 703972792

Solveig Röisgård

Role: CONTACT

solveig.roisgard@regionjh.se

+46 702791831

Facility Contacts

Solveig Röisgård, MD

Role: primary

solveig.roisgard@regionjh.se

+46702791831

Christina West, MD, PhD

Role: backup

christina.west@umu.se

+46703972792

Other Identifiers

F07

Identifier Type: -

Identifier Source: org_study_id