NCT03819556

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

April 20, 2018

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
Last Updated

May 20, 2020

Status Verified

May 1, 2020

Enrollment Period

6.5 years

First QC Date

April 20, 2018

Last Update Submit

May 19, 2020

Conditions

Milk Allergy

Keywords

Cow milk allergyOral immune therapyBasophil activation testIgEMicrobiomeQuality of life

Outcome Measures

Primary Outcomes (1)

  • Number of participants that achieve tolerance to milk

    Tolerance is defined as absence of IgE-mediated allergic symptoms connected to a double-blind placebo-controlled milk challenge

    3.5 years after start of treatment

Secondary Outcomes (9)

  • Changes in level of basophil activation (CD sens) in blood

    At baseline, after 6 months, after 3.5 years

  • Changes in Quality Of Life: FAQLQ-PF

    At baseline, after 3.5 years

  • Changes in nutritional status

    At baseline, after 3.5 years

  • Frequency of treatment-demanding adverse effects

    3.5 years

  • Changes in level of IgE milk in blood

    Baseline, 6 months, 3.5 years

  • +4 more secondary outcomes

Study Arms (2)

Active immunotherapy with milk protein

ACTIVE COMPARATOR

Daily dose fresh milk protein increased in 11 steps

Other: Milk protein in fresh milk

Control

NO INTERVENTION

Diet free from milk protein

Interventions

Milk protein in fresh milkOTHER

Milk protein in increasing doses.

Active immunotherapy with milk protein

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Solveig Röisgård

Östersund, Jämtland Härjedalen, 83183, Sweden

RECRUITING

MeSH Terms

Conditions

Milk Hypersensitivity

Interventions

Milk Proteins

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Animal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaMilkDairy ProductsFood and Beverages

Study Officials

  • Christina E West, MD,PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina West, Associated professor

CONTACT

+46 703972792christina.west@umu.se

Solveig Röisgård

CONTACT

+46 702791831solveig.roisgard@regionjh.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open randomized interventional study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor/Principal investigator

Study Record Dates

First Submitted

April 20, 2018

First Posted

January 28, 2019

Study Start

April 20, 2018

Primary Completion

October 20, 2024

Study Completion

October 20, 2024

Last Updated

May 20, 2020

Record last verified: 2020-05

Locations

SE(1)