Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Swedish Study of Immunotherapy for Milk Allergy in Children (SWITCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03819556
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Christina West, Umeå University

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.

Condition or disease Intervention/treatment Phase
Milk Allergy Other: Milk protein in fresh milk Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open randomized interventional study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Swedish Study of Immunotherapy for Milk Allergy in Children
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : October 20, 2024
Estimated Study Completion Date : October 20, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Casein

Arm Intervention/treatment
Active Comparator: Active immunotherapy with milk protein
Daily dose fresh milk protein increased in 11 steps
Other: Milk protein in fresh milk
Milk protein in increasing doses.

No Intervention: Control
Diet free from milk protein



Primary Outcome Measures :
  1. Number of participants that achieve tolerance to milk [ Time Frame: 3.5 years after start of treatment ]
    Tolerance is defined as absence of IgE-mediated allergic symptoms connected to a double-blind placebo-controlled milk challenge


Secondary Outcome Measures :
  1. Changes in level of basophil activation (CD sens) in blood [ Time Frame: At baseline, after 6 months, after 3.5 years ]
    Level of basophil activation at baseline, after dose escalation and after maintenance therapy and one additional week free from milk proteins

  2. Changes in Quality Of Life: FAQLQ-PF [ Time Frame: At baseline, after 3.5 years ]
    Quality Of Life, reported by questionnaire (FAQLQ-PF) after completion of the intervention (3.5 years) compared to pre-trial baseline level. The scale used is Emotional Impact, Food Related anxiety and Dietary Limitations. Each question of the FAQLQ is answered on a 7-point scale. Total FAQLQ scores and domain scores are calculated by dividing the sum of completed items by the number of completed items. Total FaQLQ and domain scores range from 1 "no impairment" to 7 "maximal impairment". Higher values are a worse outcome (low health related quality of life). Subscale is Health related quality of life (HRQoL summary score=(Emotional Impact subscale score + Food Related anxiety subscale score+Dietary Limitations subscale score)/3.

  3. Changes in nutritional status [ Time Frame: At baseline, after 3.5 years ]
    Body Mass Index (BMI) after completion of the intervention (3.5 years) compared to pre-trial baseline levels

  4. Frequency of treatment-demanding adverse effects [ Time Frame: 3.5 years ]
    Number of events with adrenaline injection within 2 hours after a dose of milk (one or two injections) during step-up and maintenance therapy respectively. Number of events with inhalation of bronchodilatator within 2 hours after a dose of milk during step up and maintenance therapy respectively. Number of participants with two or more events with adrenaline injections during step-up and maintenance respectively. Number of participants with two or more events with inhalation of bronchodilatator during step-up and maintenance therapy respectively. Number of participants with no events of adrenaline injections. Number of participants with no events of inhalation with bronchodilatator.

  5. Changes in level of IgE milk in blood [ Time Frame: Baseline, 6 months, 3.5 years ]
    Level of IgE milk including the components IgE casein, IgE lactoglobulin and lactalbumin at baseline, after dose escalation and after maintenance therapy and one additional week free from milk proteins

  6. Changes in level of IgG4 milk in blood [ Time Frame: Baseline, 6 months, 3.5 years ]
    Level of IgG4 milk at baseline, after dose escalation and after maintenance therapy and one additional week free from milk proteins

  7. Changes in level of IgA in saliva [ Time Frame: Baseline, 6 months, 3.5 years ]
    Level of IgA at baseline, after dose escalation and after maintenance therapy and one additional week free from milk proteins

  8. Changes in overall microbial composition in stools [ Time Frame: Baseline, 6 months, 3.5 years ]
    The overall microbial composition at baseline, after dose escalation and after maintenance therapy and one additional week free from milk proteins will be assessed using amplicon sequencing

  9. Changes in overall microbial composition in saliva [ Time Frame: Baseline, 6 months, 3.5 years ]
    The microbial composition at baseline, after dose escalation and after maintenance therapy and one additional week free from milk proteins will be assessed using amplicon sequencing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819556


Contacts
Layout table for location contacts
Contact: Christina West, Associated professor +46 703972792 christina.west@umu.se
Contact: Solveig Röisgård +46 702791831 solveig.roisgard@regionjh.se

Locations
Layout table for location information
Sweden
Solveig Röisgård Recruiting
Östersund, Jämtland Härjedalen, Sweden, 83183
Contact: Solveig Röisgård, MD    +46702791831    solveig.roisgard@regionjh.se   
Contact: Christina West, MD, PhD    +46703972792    christina.west@umu.se   
Sponsors and Collaborators
Umeå University
Investigators
Layout table for investigator information
Principal Investigator: Christina E West, MD,PhD Umeå University

Layout table for additonal information
Responsible Party: Christina West, Associate professor/Principal investigator, Umeå University
ClinicalTrials.gov Identifier: NCT03819556    
Other Study ID Numbers: F07
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina West, Umeå University:
Cow milk allergy
Oral immune therapy
Basophil activation test
IgE
Microbiome
Quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action