Walnut Oral Immunotherapy for Tree Nut Allergy
关键词
抽象
描述
Tree nut
日期
| 最后验证: | 02/28/2014 |
| 首次提交: | 04/11/2013 |
| 提交的预估入学人数: | 04/11/2013 |
| 首次发布: | 04/16/2013 |
| 上次提交的更新: | 06/15/2016 |
| 最近更新发布: | 06/16/2016 |
| 实际学习开始日期: | 10/31/2013 |
| 预计主要完成日期: | 11/30/2013 |
| 预计完成日期: | 11/30/2013 |
状况或疾病
干预/治疗
Drug: Walnut protein flour
Drug: Oat flour
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Walnut protein flour Walnut protein flour that is ingested in gradually increasing amounts up to a maintenance dose. | Drug: Walnut protein flour Daily ingestion of gradually increasing amounts of walnut protein flour in order to induce desensitization to walnut and an unrelated tree nut. |
| Placebo Comparator: Oat flour Oat flour administered in identical increasing amounts as the active walnut protein flour. | Drug: Oat flour Oat flour that is administered as a placebo in identical increasing doses as the active walnut flour treatment. |
资格标准
| 有资格学习的年龄 | 6 Years 至 6 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Age 6 to 45 years, either sex, any race, any ethnicity with a convincing clinical history of walnut or another tree nut allergy and either a positive prick skin test (> 3mm) or serologic evidence of allergic sensitization (defined as specific IgE > 0.35 kU/L) to walnut and at least one other tree nut. - A positive 2000 mg oral food challenge at enrollment to walnut and to one other tree nut. - Written informed consent from participant and/or parent/guardian - Written assent from all subjects as appropriate - All females of child bearing age must be using appropriate birth control Exclusion Criteria: - History of severe anaphylaxis to walnut or other tree nuts, defined as symptoms associated with hypoxia, hypotension or neurologic compromise (cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence). - Known allergy to oat - Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy or other respiratory or medical conditions deemed by the investigator to put the subject at increased risk of anaphylaxis or poor outcomes from receiving OIT or undergoing food challenge. - Poor control or persistent activation of atopic dermatitis - Active eosinophilic or other inflammatory (e.g., celiac) gastrointestinal disease in the past 2 years. - Participation in any interventional study for food allergy in the past 6 months - Participant is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). - Severe asthma (2007 NHLBI Criteria Steps 5 or 6, see Appendix 2) or poorly controlled mild or moderate asthma - Inability to discontinue antihistamines for initial day escalation, skin testing or OFC - Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year - Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers - Pregnancy or lactation |
结果
主要结果指标
1. Effectiveness of walnut oral immunotherapy (WOIT) on clinical desensitization to a second tree nut. [38 weeks]
次要成果指标
1. Percentage of subjects who can tolerate a 5000mg oral food challenge to walnut protein following the desensitization phase of the study [38 weeks]
2. The percentage of subjects who are able to reach a cumulative protein dose of 2000mg at the desensitization oral food challenge to walnut and the test tree nut. [38 weeks]
3. The percentage of subjects who demonstrate clinical tolerance at the end of the study to walnut and the test tree nut. [36 months]
其他成果措施
1. Increase in walnut and test tree nut IgG4 over the course of the study. [36 months]
2. Decrease in the walnut and test tree nut specific IgE over the course of the study. [36 months]
