None listed
Conditions
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.
Interventions
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 accide
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
Sponsors
Ayca Kiykim
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Months to 36 Months
Healthy volunteers
No
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).
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.
Outcome results
None listed