Efficacy of Oral Tolerance Induction to Raw Apple Using an Ultra Rush Protocol in 28 Rosacea Allergic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- Patients' tolerance to Golden apple re-consumption according to a Visual Analogue Scale (VAS)
研究概览
简要总结
The aim of the study was to describe an intensive ultra rush (UR) protocol of raw Golden apple (RGA) reintroduction in 28 in-patients, show the protocol's tolerance and the patients' follow-up at 2 months and 1 year. Patients with oral allergic syndrome (OAS) having resulted in raw fruits eviction were admitted to day hospital between June 1 2016 and October 31 2017.
详细描述
The aim of this study was to describe an intensive ultra rush (UR) protocol of raw Golden apple (RGA) reintroduction in 28 in-patients, show the protocol's tolerance and the patients' follow-up at 2 months and 1 year. Patients with oral allergic syndrome (OAS) having resulted in raw fruits eviction were admitted to day hospital between June 1 2016 and October 31 2017.
Methods : Patients were included during the first consultation, UR was performed with RGA in day hospital performed in two institutions, the Charcot clinic and the polyclinic of Beaujolais.
Starting with 1 gram (g) of food, then by regularly doubling dose from 2g to 128g, to reach a 255g cumulative dose in a 3 hour period.
During the the post hospitalization period, patients back home had to eat ½ RGA a day during one month, then 1 RGA a day during one month, together with other rosacea fruits resumption at the end of the 5th week if UR were performed between April 15th and July 15th. A synthesis consultation was made at two months and a telephone interview at one year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No longer eat raw rosacea for at least 6 months due to oral allergic syndrome
- •With allergic rhinitis or asthma due to betulaceae pollen (SPT+ and/or IgE + to Bet v 1 > 0,10 kUA/L)
- •With reduced quality of life
排除标准
- •With severe allergic reaction to rosacea (>Grade 3 according to Ring and Messmer's classification)
- •Pregnant woman
- •Uncontrolled asthma (FEV1 < 70%)
- •Immunosuppressed patient or having malignant disease, current infectious disease, or serious cardiovascular disease
- •Opposed to use data
结局指标
主要结局
Patients' tolerance to Golden apple re-consumption according to a Visual Analogue Scale (VAS)
时间窗: [Time Frame: Day 1]
Evaluation of the patients' tolerance to apple re-consumption was made during the ultra-rush protocol according to a scale inspired by the Hansen et al. classification, but the VAS used was graduated from 0 to 10 (and not from 0 to 3). This scale was enhanced with a three-color rule: the scale measured 3 levels of Oral Allergic Syndrome (OAS) severity: with no or mild side effects associated with the green color (0 to 3 on the scale), with moderate side effect associated with the orange color (4 to 6 on the scale) defined as moderate OAS (limited to oral cavity), and with severe side effect associated with red color (7 to 10 on the scale) defined as severe OAS (oral cavity together with systemic symptoms). Green color corresponds to good tolerability, orange color to mixed results, and red color is correlated to poor tolerability.
次要结局
- Ultra-Rush incidence on peak-flow (in liters/mn)([Time Frame: Day 1])
- Procedure's safety on side effects according to a Visual Analogue Scale (VAS)([Time Frame: Day 1])
- Ultra-Rush incidence on pulse rate (in bpm)([Time Frame: Day 1])
- Ultra-Rush incidence on blood pressure constants (in mmHg)([Time Frame: Day 1])
- Tolerance of apple re-consumption on a daily basis during the 2 months following ultra-rush([Time Frame: Day 1])
- Tolerance of apple and other raw rosacea re-consumption two months post- Ultra-Rush for patients treated between mid-April and mid-July, according to a Visual Analogue Scale (VAS)([Time Frame: Day 1])
- Number of participants eating rosacea with no or mild OAS at 1 year([Time Frame: Day 1])
- Biological sensitization profile of patients included([Time Frame: Day 1])
研究者
Michel Bouvier
Principal Investigator
Centre d'Allergologie du Beaujolais