Induction of immune tolerance in patients with severe food allergy through combination of oral immunotherapy and fructooligosaccharide

Samsung Medical Center0 个研究点目标入组 168 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•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).

•- 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

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