None listed
Conditions
Interventions
Medical Device : Study Group: Investigational Medical Device
Control Group: Avoidance Strategy
Duration of Digital Therapeutics Treatment: Total of 36 weeks
Visit Schedule: Total of 6 outpatient visi
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals aged between 3 and 18 years (inclusive). 2. Individuals who meet at least one of the following conditions: ? Diagnosed with an immunoglobulin E (IgE)-mediated food allergy to one or more of the following foods: egg, milk, wheat, or peanut, confirmed by an oral food challenge (OFC). ? Have a serum specific IgE level = 0.35 kU/L for egg, milk, wheat, or peanut, measured within 48 weeks prior to the screening date, and exhibit typical clinical symptoms of food allergy* to the relevant food. * Typical clinical manifestations of food allergy: onset of common allergic symptoms within 4 hours after ingestion of the food (e.g., urticaria, pruritus, rash, eczema, facial/eye/lip swelling, vomiting, diarrhea, abdominal pain, cough, rhinorrhea, wheezing, dyspnea, cyanosis, hypotension, loss of consciousness), with repeated symptoms consistently triggered by the same food. 3. Have a caregiver who is in regular contact with the subject. ** The caregiver must be able to support the subject during the trial (e.g., monitor compliance and report the subject’s condition) and spend at least 8 hours per week with the subject. 4. The subject and their legal guardian voluntarily agree to participate in the clinical trial and provide written informed consent. 5. Individuals who are willing and able to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Individuals with chronic diseases requiring treatment (e.g., heart disease, diabetes). 2. Individuals diagnosed with uncontrolled asthma or atopic dermatitis. 3. Individuals with a history of anaphylactic shock, or those who experience anaphylactic shock during the screening oral food challenge (OFC) after ingesting a small amount of food (e.g., egg 100 mg, milk 0.1 mL, wheat 100 mg, or peanut 100 mg). 4. Individuals who have received omalizumab for the treatment of chronic allergic conditions within the past 12 weeks. 5. If the caregiver is deemed unable to adequately support trial participation due to one or more of the following: ? Inability to properly manage an epinephrine auto-injector; ? Presence of cognitive impairment that makes it difficult to perform therapy using the investigational medical device or to operate general-purpose equipment such as smartphones; ? Lack of a smartphone compatible with the investigational device application (i.e., Android phones with Android 10 or higher, or iPhones iOS 13.0 or later, typically models released after 2020). 6. Individuals currently participating in another clinical trial or who have participated in another clinical trial within 4 weeks prior to the screening date. 7. Any other condition that, in the opinion of the investigator, would make participation ethically inappropriate or compromise the validity of the trial results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Desensitization rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in mechanistic biomarkers;Number of unscheduled hospital visits;Psychological assessment;Threshold of food intake;Device Compliance;Duration of the up-dosing phase;Satisfaction with the investigational medical device | — |
Countries
Korea, Republic of
Contacts
Public ContactMinhee Lee
Samsung Medical Center
Outcome results
None listed