Can Milk Allergic Patients Tolerate Baked Milk ProductsNCT01760837
Oral Immunotherapy With Baked Milk Products for Patients Allergic to Cow's Milk - A Multicenter Study
A study testing Baked milk products to cow's milk allergic patients in people with Can Milk Allergic Patients Tolerate Baked Milk Products, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
Based on the current knowledge, the investigators hypothesized that most children with milk allergy in Israel would be able to ingest baked milk products daily, thus benefiting from improved nutrition and dietary variety and protect them from accidental exposure to milk-containing products. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Can Milk Allergic Patients Tolerate Baked Milk Products
- What is being tested?
- Baked milk products to cow's milk allergic patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2013to Nov 2015
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- eligible subjects will be aged 1 to 18 years,
- had positive skin prick test (SPT) responses or detectable serum milk-specific IgE, and
- had a history of an allergic reaction to milk within 6 months before study entry or milk-specific IgE levels or SPT responses greater than 95% of predicted value for clinical reactivity (if <2 years old, a level >5 kUA/L;
- if >2 years old, a level >15 kUA/L; SPT mean wheal diameter, >8 mm.
Who cannot join
- include a negative SPT response and an undetectable milk-specific IgE level;
- a history of anaphylaxis requiring intensive care unit hospitalization;
- unstable asthma or a history of intubation related to asthma;
- previously diagnosed milk-induced eosinophilic gastroenteropathy;
- a recent reaction (within 6 months) to a baked milk product; or
- pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Based on the current knowledge, the investigators hypothesized that most children with milk allergy in Israel would be able to ingest baked milk products daily, thus benefiting from improved nutrition and dietary variety and protect them from accidental exposure to milk-containing products.
Objective: The aim of our study is to examine the outcome of cow's milk allergic patients who incorporated baked milk products into their diets. In order to recruit a large population, a multicenter study across many hospital related allergy clinics in Israel will be conducted.
Read more
Methods
Participants The study protocol is essentially as described previously (12). Subjects will be recruited from the relevant allergy clinics involved in this project. The study will be approved by the local Institutional Review Board, and informed consent will be obtained.
Eligible subjects will be aged 1 to 18 years, had positive skin prick test (SPT) responses or detectable serum milk-specific IgE, and had a history of an allergic reaction to milk within 6 months before study entry or milk-specific IgE levels or SPT responses greater than 95% of predicted value for clinical reactivity (if <2 years old, a level >5 kUA/L; if >2 years old, a level >15 kUA/L; SPT mean wheal diameter, >8 mm.
Exclusion criteria include a negative SPT response and an undetectable milk-specific IgE level; a history of anaphylaxis requiring intensive care unit hospitalization; unstable asthma or a history of intubation related to asthma; previously diagnosed milk-induced eosinophilic gastroenteropathy; a recent reaction (within 6 months) to a baked milk product; or pregnancy.
Design
Active group - Based on the results of the initial baked milk oral challenge, subjects will be categorized as baked milk reactive or baked milk tolerant (group I and II, respectively). Group I subjects will be instructed to completely avoid all forms of milk but will be offered a repeat challenge 6 or more months from the initial challenge. Group II subjects will be instructed to incorporate baked milk products daily into their diets and after 6 or more months will be offered challenges to baked cheese products (pizza). Similarly, after 6 or more months, baked cheese-tolerant children will be offered challenges to unheated milk.
The two groups will be followed at least 2 years and the outcome as well as other parameters (accidental exposure, use of medication, quality of life, appearance of related symptoms, ect) will be compared between the 2 groups.
Baked milk - Each muffin (or the equivalent piece of cake) contains ~ 1.3 g of milk protein. The muffins/cake will be prepared according to instructed recipe and will be baked at 180 degree C for 30 minutes. Baked milk-tolerant subjects will be instructed to ingest 1 to 3 servings per day of store-bought baked milk products with milk listed as a minor ingredient (third or less) or home-baked products with an equivalent amount of milk protein.
Baked cheese - Cheese pizza (Maadanot), will be baked at 2200 C for 13 minutes or longer. Baked cheese-tolerant subjects will be instructed to eat any brand of well-cooked cheese pizza 4 to 7 times weekly and limited to 1 daily serving.
Unheated milk - Challenges will be performed with skim milk totaling 240 mL (or other product containing 8-10 g of unheated milk protein, such as yogurt).
Follow-up allergy evaluations - Blood and serum samples will be collected for the measurement of IgE and IgG4 antibodies to milk, casein, and b-lactoglobulin by using UniCAP (Phadia, Uppsala, Sweden) as well as for T cell analyses. (This part is optional upon agreement of the parents).
Un-blinded food challenges will be performed under a physician's supervision in the clinical research unit. Muffin and pizza will be administered in 4 equal portions over 1 hour. Unheated milk will be administered in gradually increasing doses. Subjects will be monitored throughout and for 2 to 4 hours after completion of the challenge. Challenges will be discontinued at the first objective sign of a reaction or due to convincing persistent subjective symptoms, and appropriate treatment will be initiated immediately.
- Being tested
- Baked milk products to cow's milk allergic patients
- Keywords
- cow's milk allergy, baked milk, tolerance, infants and children
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baked milk products to cow's milk allergic patientsOther
| Study group | Role | What they receive |
|---|---|---|
| baked milk products, cow's milk allergy | Other | to offer baked milk products to cow's milk allergic patients and to follow them for tolerance and if this intervention may have any impact on the natural history of milk allergy Receives: Other: Baked milk products to cow's milk allergic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients who will tolerated cow's milk
Measured: two years following the first baked milk challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Can Milk Allergic Patients Tolerate Baked Milk ProductsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760837
- Sponsor's protocol ID
- 0140-12-WOMC
- Status last verified
- Nov 2012
- First submitted
- 1 Jan 2013
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Immunotherapy With Baked Milk Products for Patients Allergic to Cow's Milk - A Multicenter Study
- ClinicalTrials.gov ID
- NCT01760837
- Acronym / sponsor ID
- 0140-12-WOMC
- Keywords
- cow's milk allergy, baked milk, tolerance, infants and children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Jan 2013 (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.
Based on the current knowledge, the investigators hypothesized that most children with milk allergy in Israel would be able to ingest baked milk products daily, thus benefiting from improved nutrition and dietary variety and protect them from accidental exposure to milk-containing products.
Objective: The aim of our study is to examine the outcome of cow's milk allergic patients who incorporated baked milk products into their diets. In order to recruit a large population, a multicenter study across many hospital related allergy clinics in Israel will be conducted.
Methods
Participants The study protocol is essentially as described previously (12). Subjects will be recruited from the relevant allergy clinics involved in this project. The study will be approved by the local Institutional Review Board, and informed consent will be obtained.
Eligible subjects will be aged 1 to 18 years, had positive skin prick test (SPT) responses or detectable serum milk-specific IgE, and had a history of an allergic reaction to milk within 6 months before study entry or milk-specific IgE levels or SPT responses greater than 95% of predicted value for clinical reactivity (if <2 years old, a level >5 kUA/L; if >2 years old, a level >15 kUA/L; SPT mean wheal diameter, >8 mm.
Exclusion criteria include a negative SPT response and an undetectable milk-specific IgE level; a history of anaphylaxis requiring intensive care unit hospitalization; unstable asthma or a history of intubation related to asthma; previously diagnosed milk-induced eosinophilic gastroenteropathy; a recent reaction (within 6 months) to a baked milk product; or pregnancy.
Design
Active group - Based on the results of the initial baked milk oral challenge, subjects will be categorized as baked milk reactive or baked milk tolerant (group I and II, respectively). Group I subjects will be instructed to completely avoid all forms of milk but will be offered a repeat challenge 6 or more months from the initial challenge. Group II subjects will be instructed to incorporate baked milk products daily into their diets and after 6 or more months will be offered challenges to baked cheese products (pizza). Similarly, after 6 or more months, baked cheese-tolerant children will be offered challenges to unheated milk.
The two groups will be followed at least 2 years and the outcome as well as other parameters (accidental exposure, use of medication, quality of life, appearance of related symptoms, ect) will be compared between the 2 groups.
Baked milk - Each muffin (or the equivalent piece of cake) contains ~ 1.3 g of milk protein. The muffins/cake will be prepared according to instructed recipe and will be baked at 180 degree C for 30 minutes. Baked milk-tolerant subjects will be instructed to ingest 1 to 3 servings per day of store-bought baked milk products with milk listed as a minor ingredient (third or less) or home-baked products with an equivalent amount of milk protein.
Baked cheese - Cheese pizza (Maadanot), will be baked at 2200 C for 13 minutes or longer. Baked cheese-tolerant subjects will be instructed to eat any brand of well-cooked cheese pizza 4 to 7 times weekly and limited to 1 daily serving.
Unheated milk - Challenges will be performed with skim milk totaling 240 mL (or other product containing 8-10 g of unheated milk protein, such as yogurt).
Follow-up allergy evaluations - Blood and serum samples will be collected for the measurement of IgE and IgG4 antibodies to milk, casein, and b-lactoglobulin by using UniCAP (Phadia, Uppsala, Sweden) as well as for T cell analyses. (This part is optional upon agreement of the parents).
Un-blinded food challenges will be performed under a physician's supervision in the clinical research unit. Muffin and pizza will be administered in 4 equal portions over 1 hour. Unheated milk will be administered in gradually increasing doses. Subjects will be monitored throughout and for 2 to 4 hours after completion of the challenge. Challenges will be discontinued at the first objective sign of a reaction or due to convincing persistent subjective symptoms, and appropriate treatment will be initiated immediately.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| baked milk products, cow's milk allergy | Other | Other: Baked milk products to cow's milk allergic patientsto offer baked milk products to cow's milk allergic patients and to follow them for tolerance and if this intervention may have any impact on the natural history of milk allergy |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- eligible subjects will be aged 1 to 18 years,
- had positive skin prick test (SPT) responses or detectable serum milk-specific IgE, and
- had a history of an allergic reaction to milk within 6 months before study entry or milk-specific IgE levels or SPT responses greater than 95% of predicted value for clinical reactivity (if <2 years old, a level >5 kUA/L;
- if >2 years old, a level >15 kUA/L; SPT mean wheal diameter, >8 mm.
Key exclusion criteria (6 listed)
- include a negative SPT response and an undetectable milk-specific IgE level;
- a history of anaphylaxis requiring intensive care unit hospitalization;
- unstable asthma or a history of intubation related to asthma;
- previously diagnosed milk-induced eosinophilic gastroenteropathy;
- a recent reaction (within 6 months) to a baked milk product; or
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 |
|---|---|---|
| Baked milk products to cow's milk allergic patients | Other | baked milk products, cow's milk allergy |
Primary outcome
patients who will tolerated cow's milk
Time frame: two years following the first baked milk challenge
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 11 Dec 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baked milk products to cow's milk allergic patients in people with Can Milk Allergic Patients Tolerate Baked Milk Products, run by Wolfson Medical Center at 1 site in Israel.
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 4 inclusion and 6 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 11 Dec 2015. 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 Israel. 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?
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?
patients who will tolerated cow's milk (time frame: two years following the first baked milk challenge). 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 11 Dec 2015.