None listed
Conditions
Interventions
Dietary Supplement : Subjects will be selected according to the selection criteria and divided into egg, milk, and wheat oral immunotherapy (OIT) groups. Those who will receive prebiotics—5 g/day of A
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children and adolescents aged 3~17 who meet the following conditions. ? Positive for one or more of the following foods in the food oral provocation test conducted within the last 12 months as of the time of obtaining consent, or in the food oral provocation test conducted for medical purposes after obtaining consent was positive for one or more of the following foods: eggs, milk, or wheat. ? Specific IgE (Immuno-CAP) greater than or equal to 0.35 in blood test within the last 12 months at the time of obtaining consent, or Specific IgE (Uni-CAP) greater than or equal to 0.35 in blood test performed for medical purposes after obtaining consent. ? If the subject and his/her guardian agree to participate in the study in accordance with the plan to obtain consent/consent (preferably, the subject should be given written consent, and if written consent is not possible, it should be fully explained verbally and the verbal consent to participate should be recorded).
Exclusion criteria
Exclusion criteria: - Patients who cannot discontinue medications (systemic steroids, immunosuppressants, immunotherapies, biotherapeutics, etc.) that may affect the oral food provocation test and skin-prick test for a period that may affect the test - Patients who are constantly taking medications that affect the worsening of symptoms (beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers) during anaphylaxis - Patients with severe cardiopulmonary disease requiring ongoing treatment - Patients with systemic diseases who require a specific diet (However, if anaphylaxis occurs after ingesting eggs, milk, or wheat, it does not fall under the exclusion criteria.) - Persons who plan to participate in other clinical trials during the human application test (except for observational studies) - Those with a history of allergy to probiotics or prebiotics - Patients who are judged to be unsuitable for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in adverse events during the build-up phase of oral immunotherapy between the FOS group and the control group | — |
Secondary
| Measure | Time frame |
|---|---|
| the frequency of anaphylaxis during the build-up phase of oral immunotherapy ;desensitization in oral food challenge tests performed after oral immunotherapy;Difference and percent change from baseline in specific IgE and IgG4 levels for eggs, milk, wheat, ovomucoid, casein, and omega-5 gliadin;gut microbiome and short chain fatty acid (SCFA);Difference and percent change in fecal microbiota and short-chain fatty acids (SCFAs) between before the start of oral immunotherapy and after the end of the build-up phase | — |
Countries
Korea, Republic of
Contacts
Public ContactSoyoung Kim
Samsung Medical Center
Outcome results
None listed