Indonesian children with cow'
Conditions
Interventions
Oral immunotherapy (OIT) is administered through the oral consumption of cow'
s milk in very small amounts that are gradually increased. Prior to initiating OIT, participants undergo a controlled Oral Food Challenge (OFC) at a healthcare facility to confirm the diagnosis of cow
s milk allergy and to determine their initial clinical reaction threshold. The OFC is conducted by administering incrementally increasing doses of cow'
s milk under medical supervision to monitor for allergic symptoms. Once the diagnosis is confirmed, participants begin the dose-initiation phase in the hospital, during which a very low starting dose
s milk while being monitored for safety, adherence, and the development of tolerance. This intervention progresses through sequential dose-escalation and maintenance phases, with the overall duration
s individual response and tolerance.,Participants in the control group do not receive oral immunotherapy (OIT) and continue to follow standard management for cow'
s milk allergy. They are instructed to avoid the consumption of cow'
s milk and milk-derived products throughout the study period and to maintain their usual care as previously recommended by their physician. Participants undergo regular follow-up visits at the healthc
Experimental Other,No Intervention No treatment
OIT,Control
Sponsors
Azwin Mengindra Putera
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: Participants eligible for inclusion in this study are: 1. Children aged 1-12 years. 2. Having a diagnosis of cow's milk allergy based on a consistent clinical history. 3. The diagnosis is supported by allergy testing, such as specific IgE or skin prick testing, demonstrating sensitization to cow's milk. 4. The diagnosis is confirmed through an oral food challenge. 5. The child is in a clinically stable condition, not experiencing an exacerbation of any other allergic disorders. 6. The child has not developed tolerance to cow's milk in daily life. 7. Willing to comply with the entire oral immunotherapy (OIT) protocol, including dose-escalation visits at the hospital and the maintenance phase at home.
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they: 1. Have a history of life-threatening anaphylaxis due to exposure to cow's milk. 2. Have uncontrolled asthma or severe chronic lung disease. 3. Have other systemic conditions that may increase the risks associated with oral immunotherapy, such as: cardiac disease, immunologic disorders, malignancy, and/or active autoimmune disease. 4. Are experiencing a severe acute infection. 5. Are taking medications that may interfere with the management of allergic reactions, such as beta-blockers. 6. Are participating in other clinical interventions that could affect immune responses. 7. Have psychosocial factors or family limitations that may hinder adherence to scheduled visits or the administration of maintenance doses at home.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Desensitization to cow's milk 6 month Skin Prick Test and Oral Food Challenge | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily Activity 6 month Food Allergy Impact Scale (FAIS) | — |
Countries
Indonesia
Contacts
Public ContactAzwin Putera
Universitas Airlangga
Outcome results
None listed