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Trial registered on ANZCTR


Registration number
ACTRN12615001155583
Ethics application status
Approved
Date submitted
6/08/2015
Date registered
29/10/2015
Date last updated
20/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of baked milk to placebo in IgE mediated cow's milk allergic children in tolerance induction
Scientific title
Comparison of baked milk to placebo in IgE mediated cow's milk allergic children in tolerance induction
Secondary ID [1] 287220 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cow's milk allergy 295822 0
Condition category
Condition code
Diet and Nutrition 296080 296080 0 0
Other diet and nutrition disorders
Inflammatory and Immune System 296081 296081 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A mixture of milk powder containing 1.3 g cow's milk and wheat flour is baked in the oven for 30 min at 180 degrees Celsius. Each 60 g bread contains milk powder equal to 1.3 g cow's milk. Breads prepared for placebo include exactly the same ingredients except milk powder.
The placebo and cow's milk containing breads are supplied by the same manufacturer.
Patients' adherence is monitored by weekly phone calls and also by charts documenting daily consumpted bread amount, side effects and accidental dairy product consumption.


1. Active group: Receiving bread that contains 1.3 g baked milk, at least 60 g a day, for 12 months
2. Placebo group: Receiving bread with no milk, at least 60 g a day, for 12 months
Intervention code [1] 292507 0
Treatment: Other
Comparator / control treatment
Control group: Receiving baked bread with no milk as placebo
Control group
Placebo

Outcomes
Primary outcome [1] 295755 0
Tolerance, measured by double blind placebo controlled food challenge with raw cow's milk
Tolerance, measured by ability of raw cow's milk consumption without any adverse effects
Timepoint [1] 295755 0
baseline, 6 and 12 months
Secondary outcome [1] 316419 0
To evaluate tolerance induction by comparing following parameters at baseline, at 6 and 12 months of the study;
-skin prick test reactivity with raw cow's milk including different dilutions as 1/1, 1/100, 1/1000
-regulatory T cell proliferation response to raw cow's milk
-basophil activation test (CD63 expression) reactivity to raw cow's milk
-milk, casein, beta lactoglobulin specific IgA/IgG4/IgE levels
All those parameters will be assessed at baseline, 6 and 12 months of the study for all patients
Timepoint [1] 316419 0
baseline, 6 and 12 months

Eligibility
Key inclusion criteria
IgE mediated cow's milk allergic patients, with a positive skin prick test (SPT) or detectable serum milk-specific IgE and an allergic reaction within six months before study entry, or milkspecific IgE levels or SPT highly predictive for clinical reactivity (if <2 years old, a level>5kUA/L; if>2years old, a level>15kUA/L; SPT wheal diameter >8 mm).
Minimum age
6 Months
Maximum age
36 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Negative SPT and undetectable milk-specific
IgE; unstable asthma, allergic rhinitis, or atopic dermatitis;milk-induced eosinophilic
gastroenteropathy; a recent reaction to a heated milk-product.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Double blind placebo controlled food challenge (DBPCFC) with 1.3 g baked milk powder containing bread will be performed at the baseline for all participants.
Patients with no reactions will be included to the study, randomly as active or placebo group (central randomisation by computer). Daily consumption of baked milk will be provided during 12 months of period. The patients consuming bread with baked milk or with no milk will be assessed 6 and 12 months later with DBPCFC raw cow’s milk.
Patients continuing milk free diet will be assessed 6 and 12 months later with bread containing 1.3 g baked milk.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 7080 0
Turkey
State/province [1] 7080 0

Funding & Sponsors
Funding source category [1] 291792 0
University
Name [1] 291792 0
Marmara University Scientific Research Projects Office
Country [1] 291792 0
Turkey
Primary sponsor type
Individual
Name
Ayca Kiykim
Address
Marmara Medical Faculty, Fevzi Cakmak Mahallesi, Mimar Sinan Caddesi, NO:41, Pendik, 34899, Istanbul
Country
Turkey
Secondary sponsor category [1] 290453 0
None
Name [1] 290453 0
Address [1] 290453 0
Country [1] 290453 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293309 0
Marmara University Ethics Committee
Ethics committee address [1] 293309 0
Ethics committee country [1] 293309 0
Turkey
Date submitted for ethics approval [1] 293309 0
Approval date [1] 293309 0
07/03/2014
Ethics approval number [1] 293309 0

Summary
Brief summary
Cow’s milk allergy is the important cause of food related anaphylaxis during childhood. It is classified under IgE related and non IgE food allergy. Although general aspect is strict avoidance of dairy product consumption, accidental reactions like anaphylaxis occur. Besides, strict avoidance of cow’s milk products in this age group of 6 months to 4 years compromise the physical development of those children. Some of them may tolerate processed dairy products. Baking is one of the methods for processing cow’s milk to break the 3-D construction and decrease the allergenicity. Previous studies report that 65-80 % of cow’s milk allergic children may tolerate baked milk.
Patients who admitted to our outpatient clinic with allergic symptoms developing after cow’s milk consumption with IgE related mechanisms verified by either positive specific milk IgE or skin prick test, aged between 6 to 36 months will be included. Double blind placebo controlled (DBPC) baked milk challenge will be performed then patients who tolerate baked milk will be randomized. Active group will consume baked milk while the placebo group will consume milk free bread for 12 months, then DBPC milk challenge tests will be performed. Children unable to tolerate baked milk at the beginning remain free of cow’s milk during the study. Immunologic parameters will be noted in all stages and evaluated at the end of the study. Although partial tolerance (allergic reaction with higher allergen doses) develops during the process it will be our secondary income to decrease anaphylaxis risk.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59334 0
Dr Ayca Kiykim
Address 59334 0
Marmara University Hospital Pediatric Allergy and Immunology Fevzi
Cakmak Mahallesi, Mimar Sinan Caddesi, No: 41, Postal code: 34899
Pendik/Istanbul
Country 59334 0
Turkey
Phone 59334 0
+905423432245
Fax 59334 0
Email 59334 0
[email protected]
Contact person for public queries
Name 59335 0
Ismail Cinel
Address 59335 0
Marmara University Hospital
Fevzi Cakmak Mahallesi, Mimar Sinan Caddesi, No: 41, Postal code: 34899
Pendik/Istanbul
Country 59335 0
Turkey
Phone 59335 0
+90 532 4129596
Fax 59335 0
Email 59335 0
[email protected]
Contact person for scientific queries
Name 59336 0
Safa Baris
Address 59336 0
Marmara University Hospital Pediatric Allergy and Immunology Fevzi
Cakmak Mahallesi, Mimar Sinan Caddesi, No: 41, Postal code: 34899
Pendik/Istanbul
Country 59336 0
Turkey
Phone 59336 0
+905052614986
Fax 59336 0
Email 59336 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3997Plain language summaryNo BACKGROUND AND OBJECTIVES: About 65-80% of childr... [More Details]
4554Study results articleYes Send to Int Arch Allergy Immunol. 2018 Nov 7:1-9.... [More Details]

Documents added automatically
No additional documents have been identified.