Milk AllergySWITCHNCT03819556
Swedish Study of Immunotherapy for Milk Allergy in Children
A study testing Milk protein in fresh milk in people with Milk Allergy, run by Umeå University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Milk Allergy
- What is being tested?
- Milk protein in fresh milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 20 Apr 2018to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Immunoglobulin E (IgE) milk >0.1 kU/L
- Allergic reaction within 2 hours after intake of milk protein
- Age 5-15 years
Who cannot join
- 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
Show all 9Show fewer
- Eosinophil esophagitis
- Pregnancy and breastfeeding
- Ongoing immunotherapy to one or more allergens
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Solveig Röisgård
Östersund, Jämtland Härjedalen, 83183
Solveig Röisgård, MD, +46702791831, solveig.roisgard@regionjh.se
Christina West, MD, PhD, +46703972792, christina.west@umu.se
About this study
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.
Read the 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
- Being tested
- Milk protein in fresh milk
- Keywords
- Cow milk allergy, Oral immune therapy, Basophil activation test, IgE, Microbiome, Quality of life
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk protein in fresh milkOther
Milk protein in increasing doses.
| Study group | Role | What they receive |
|---|---|---|
| Active immunotherapy with milk protein | Active comparator | Daily dose fresh milk protein increased in 11 steps Receives: Other: Milk protein in fresh milk |
| Control | No intervention | Diet free from milk protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3.5 years after start of treatment
Secondary outcomes (9)
Changes in level of basophil activation (CD sens) in blood
Level of basophil activation at baseline, after dose escalation and after maintenance therapy and one additional week free from milk proteins
Measured: At baseline, after 6 months, after 3.5 years
Changes in Quality Of Life: FAQLQ-PF
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.
Measured: At baseline, after 3.5 years
Changes in nutritional status
Body Mass Index (BMI) after completion of the intervention (3.5 years) compared to pre-trial baseline levels
Measured: At baseline, after 3.5 years
Frequency of treatment-demanding adverse effects
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.
Measured: 3.5 years
Changes in level of IgE milk in blood
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
Measured: Baseline, 6 months, 3.5 years
Changes in level of IgG4 milk in blood
Level of IgG4 milk at baseline, after dose escalation and after maintenance therapy and one additional week free from milk proteins
Measured: Baseline, 6 months, 3.5 years
Changes in level of IgA in saliva
Level of IgA at baseline, after dose escalation and after maintenance therapy and one additional week free from milk proteins
Measured: Baseline, 6 months, 3.5 years
Changes in overall microbial composition in stools
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
Measured: Baseline, 6 months, 3.5 years
Changes in overall microbial composition in saliva
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
Measured: Baseline, 6 months, 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start20 Apr 2018
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Milk AllergyStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open randomized interventional study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina West, Umeå University
- Investigators
- Christina E West, MD,PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819556
- Sponsor's protocol ID
- F07
- Acronym
- SWITCH
- Status last verified
- May 2020
- First submitted
- 20 Apr 2018
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swedish Study of Immunotherapy for Milk Allergy in Children
- ClinicalTrials.gov ID
- NCT03819556
- Acronym / sponsor ID
- SWITCH / F07
- Conditions
- Milk Allergy
- Keywords
- Cow milk allergy, Oral immune therapy, Basophil activation test, IgE, Microbiome, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open randomized interventional study
| Arm | Type | Receives |
|---|---|---|
| Active immunotherapy with milk protein | Active comparator | Other: Milk protein in fresh milkDaily dose fresh milk protein increased in 11 steps |
| Control | No intervention | –Diet free from milk protein |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Immunoglobulin E (IgE) milk >0.1 kU/L
- Allergic reaction within 2 hours after intake of milk protein
- Age 5-15 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk protein in fresh milkMilk protein in increasing doses. | Other | Active immunotherapy with milk protein |
Primary outcome
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
9 secondary outcomes
Changes in level of basophil activation (CD sens) in blood
Time frame: At baseline, after 6 months, after 3.5 years
Changes in Quality Of Life: FAQLQ-PF
Time frame: At baseline, after 3.5 years
Changes in nutritional status
Time frame: At baseline, after 3.5 years
Frequency of treatment-demanding adverse effects
Time frame: 3.5 years
Changes in level of IgE milk in blood
Time frame: Baseline, 6 months, 3.5 years
Changes in level of IgG4 milk in blood
Time frame: Baseline, 6 months, 3.5 years
Changes in level of IgA in saliva
Time frame: Baseline, 6 months, 3.5 years
Changes in overall microbial composition in stools
Time frame: Baseline, 6 months, 3.5 years
Changes in overall microbial composition in saliva
Time frame: Baseline, 6 months, 3.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina E West, MD,PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk protein in fresh milk in people with Milk Allergy, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina West, Associated professor (+46 703972792, christina.west@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that achieve tolerance to milk (time frame: 3.5 years after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2020.