Milk AllergyPhase 4NCT01361347
Safety of Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
A Phase 4 study testing milk in people with Milk Allergy and Anaphylaxis, run by Tampere University Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Milk Allergy, Anaphylaxis
- What is being tested?
- milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2008to Dec 2016
- Phase
- Phase 4
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- IgE-mediated milk allergy
- An immediately positive challenge test result to milk prior to inclusion
Who cannot join
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Read the detailed description
Eligibility criteria:
Age 6 - 16 yrs
- IgE-mediated milk allergy
- and milk provocation within 3 months prior to or an documented accidental milk contact with clear immediate symptoms
Outcome measures:
- number of patients with successful desensitization (195 - 200 ml milk per day)
- number of patients with adverse events
- Conditions
- Milk Allergy, Anaphylaxis
- Being tested
- milk
- Keywords
- milk allergy, desensitization, anaphylaxis, school-age
- Medical subject headings
- Milk Hypersensitivity, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milkDietary supplement
Also called milk allergy, desensitization
milk for milk allergic children (1:25 dilution, whole milk)
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | rice/soy/oat "milk"drink, masked Receives: Dietary Supplement: milk |
| milk | Experimental | cow's milk Receives: Dietary Supplement: milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as a measure of safety and tolerability
Measured: 12 months
Secondary outcomes (1)
Number of participants drinking 2 dl/day of milk (success in desensitization)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startFeb 2008
- Primary completionDec 2016
- Study completionDec 2016
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 Tampere University HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marita Paassilta, Tampere University Hospital
- Investigators
- Marita Paassilta, MD, PhD, Principal investigator, Consultant Pediatric Allergist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361347
- Sponsor's protocol ID
- PaassiltaM
- Status last verified
- Jan 2017
- First submitted
- 24 Feb 2011
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study: Milk Oral Immunotherapy for Cow's Milk Allergy in School-aged Children
- ClinicalTrials.gov ID
- NCT01361347
- Acronym / sponsor ID
- PaassiltaM
- Conditions
- Milk Allergy, Anaphylaxis
- Keywords
- milk allergy, desensitization, anaphylaxis, school-age
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 May 2011 (estimated)
- 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.
The purpose of this study is to study the number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Detailed description
Eligibility criteria:
Age 6 - 16 yrs
- IgE-mediated milk allergy
- and milk provocation within 3 months prior to or an documented accidental milk contact with clear immediate symptoms
Outcome measures:
- number of patients with successful desensitization (195 - 200 ml milk per day)
- number of patients with adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: milkrice/soy/oat "milk"drink, masked |
| milk | Experimental | Dietary Supplement: milkcow's milk |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- IgE-mediated milk allergy
- An immediately positive challenge test result to milk prior to inclusion
Key exclusion criteria (1 listed)
- Not willing to participate
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 |
|---|---|---|
| milkAlso: milk allergy, desensitizationmilk for milk allergic children (1:25 dilution, whole milk) | Dietary supplement | milk, placebo |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: 12 months
1 secondary outcome
Number of participants drinking 2 dl/day of milk (success in desensitization)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
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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.
Marita Paassilta, MD, PhD principal investigator
Consultant Pediatric Allergist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing milk in people with Milk Allergy and Anaphylaxis, run by Tampere University Hospital at 1 site in Finland.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 4 Jan 2017. 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 Finland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as a measure of safety and tolerability (time frame: 12 months). 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 4 Jan 2017.