ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cow's milk allergy

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Inflammatory and Immune System

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]

Treatment: Other

Comparator / control treatment

Control group: Receiving baked bread with no milk as placebo

Control group

Placebo

Outcomes

Primary outcome [1]

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]

baseline, 6 and 12 months

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Marmara University Scientific Research Projects Office

Address [1]

Marmara Universitesi Rektorlugu
Goztepe Yerleskesi
Fahrettin Kerem Gokay Street, No: 53, Postal code: 34722
Kadikoy/Istanbul/Turkey

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Marmara University Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

Approval date [1]

07/03/2014

Ethics approval number [1]

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

Dr Ayca Kiykim

Address

Marmara University Hospital Pediatric Allergy and Immunology Fevzi
Cakmak Mahallesi, Mimar Sinan Caddesi, No: 41, Postal code: 34899
Pendik/Istanbul

Country

Turkey

Phone

+905423432245

Fax

dr_gora@yahoo.com

Contact person for public queries

Name

Ismail Cinel

Address

Marmara University Hospital
Fevzi Cakmak Mahallesi, Mimar Sinan Caddesi, No: 41, Postal code: 34899
Pendik/Istanbul

Country

Turkey

Phone

+90 532 4129596

Fax

cinelismail@yahoo.com

Contact person for scientific queries

Name

Safa Baris

Address

Marmara University Hospital Pediatric Allergy and Immunology Fevzi
Cakmak Mahallesi, Mimar Sinan Caddesi, No: 41, Postal code: 34899
Pendik/Istanbul

Country

Turkey

Phone

+905052614986

Fax

safabaris@hotmail.com

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		BACKGROUND AND OBJECTIVES: About 65-80% of childr... [More Details]
Study results article	Yes		Send to Int Arch Allergy Immunol. 2018 Nov 7:1-9.... [More Details]

Documents added automatically

No additional documents have been identified.

Trial Review

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Documents added manually

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