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Tolerance Following Peanut Oral Immunotherapy
Bu çalışma, yer fıstığı alerjisi (peanut allergy) olan kişilerde ağızdan verilen yer fıstığı unu ile uygulanan oral immünoterapiden sonra tolerans gelişimini incelemektedir; karşılaştırma için yulaf unu kullanılmıştır. Çalışmaya, deri testi ve tıbbi öykü ile yer fıstığı alerjisi doğrulanmış, 7-55 yaş arası kişiler alınmıştır. Çalışma Faz 1/Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Diagnosis of peanut allergy by a positive skin prick test to peanut (reaction wheal at least 5 mm larger than saline control) and by medical history or Serum peanut-specific IgE \>5 kU/L at screening visit. * Ara h 2 specific IgE \>0.35 kU/L at screening visit * Ability to provide informed consent. * Males and females of all ethnic/racial groups aged 7-55 years old who are otherwise healthy. * React to less than 443 mg of peanut protein during DBPCFC1 Exclusion Criteria: * History of severe anaphylaxis as defined by hypoxia (cyanosis or SpO2 \<92% during reaction), documented hypotension (documented systolic BP \>30% below predicted normal for sex, height, weight or from known baseline), neurological compromise (confusion, loss of consciousness), or incontinence. * Severe or Moderate asthma as defined using the severity criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/). * Poorly-controlled asthma as defined by FEV1 \<80% or any of the following symptoms: nighttime awakening \>2 days/week or rescue medication use \>2 days / week. * Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders * Inability to cooperate with and/or perform oral food challenge procedures. * Primary Immune Deficiency * Allergy to oat confirmed by skin prick testing and history * Current use of beta blockers, angiotensin converting enzyme inhibitors, or monoamine oxidase inhibitors * Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding * Hemoglobin level less than 12.5 gm/dL at screening. Weight \<23 kg * Use within the past 6 months of other systemic immunomodulatory treatments including allergen immunotherapy, or use of biologics with an immune target, including omalizumab. * Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study may also exclude a participant from the study.