- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03819556
Swedish Study of Immunotherapy for Milk Allergy in Children (SWITCH)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christina West, Associated professor
- Phone Number: +46 703972792
- Email: christina.west@umu.se
Study Contact Backup
- Name: Solveig Röisgård
- Phone Number: +46 702791831
- Email: solveig.roisgard@regionjh.se
Study Locations
-
-
Jämtland Härjedalen
-
Östersund, Jämtland Härjedalen, Sweden, 83183
- Recruiting
- Solveig Röisgård
-
Contact:
- Solveig Röisgård, MD
- Phone Number: +46702791831
- Email: solveig.roisgard@regionjh.se
-
Contact:
- Christina West, MD, PhD
- Phone Number: +46703972792
- Email: christina.west@umu.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Active immunotherapy with milk protein
Daily dose fresh milk protein increased in 11 steps
|
Milk protein in increasing doses.
|
No Intervention: Control
Diet free from milk protein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
3.5 years after start of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At baseline, after 6 months, after 3.5 years
|
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.
|
At baseline, after 3.5 years
|
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
|
At baseline, after 3.5 years
|
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.
|
3.5 years
|
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
|
Baseline, 6 months, 3.5 years
|
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
|
Baseline, 6 months, 3.5 years
|
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
|
Baseline, 6 months, 3.5 years
|
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
|
Baseline, 6 months, 3.5 years
|
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
|
Baseline, 6 months, 3.5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christina E West, MD,PhD, Umea University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- F07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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