Efficacy of Oral Tolerance Induction to Raw Apple

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Oral Tolerance Induction to Raw Apple Using an Ultra Rush Protocol in 28 Rosacea Allergic Patients

Conditions
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Oral Allergic Syndrome, Allergic Reaction Caused by Food (Disorder)

Intervention / Treatment
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* Other: RAAP - for Raw Apple in connection with re-contact with the raw apple according to an Ultra-Rush protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Allergic patients to raw apple and birch<br>Single-group studies about 28 patients allergic to birch and no longer eating raw rosaceae for at least 6 months. Patients brought back into contact with this family of fruits via the raw golden apple according to an Ultra-Rush protocol. | Other: RAAP - for Raw Apple in connection with re-contact with the raw apple according to an Ultra-Rush protocol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' tolerance to Golden apple re-consumption according to a Visual Analogue Scale (VAS) | 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. | [Time Frame: Day 1] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultra-Rush incidence on blood pressure constants (in mmHg) | Measurement of blood pressure constants during Ultra-Rush | [Time Frame: Day 1] | 
| Ultra-Rush incidence on pulse rate (in bpm) | Measurement of pulse in beats per minute during Ultra-Rush | [Time Frame: Day 1] | 
| Ultra-Rush incidence on peak-flow (in liters/mn) | Measurement of peak-flow in liters per minute during Ultra-Rush | [Time Frame: Day 1] | 
| Procedure's safety on side effects according to a Visual Analogue Scale (VAS) | Measurement of side effects during Ultra-Rush (UR) and for the next two months according to the Visual Analogue Scale (VAS) used for the study. The 0-10 graduated 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 (green color), with moderate side effect (orange color), and with severe side effect (red color). During UR, side effects intensity was evaluated on the VAS at each UR step. After UR and for the next two months, patients recorded daily the side effects on a notebook, using the same tool. These records were transcribed in the patients medical file by investigator. | [Time Frame: Day 1] | 
| Tolerance of apple re-consumption on a daily basis during the 2 months following ultra-rush | Evaluation of the tolerance by means of visual scale with 3 levels of stringency: without side effects (associated with the green color), with moderate side effect (associated with the orange color) and with severe side effect (associated with red color) | [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) | Tolerance was evaluated at the two months post Ultra-Rush visit, using the VAS. The 0-10 graduated 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 (green color), with moderate side effect (orange color), and with severe side effect (red color). | [Time Frame: Day 1] | 
| Number of participants eating rosacea with no or mild OAS at 1 year | During a specific interrogation in a telephone interview | [Time Frame: Day 1] | 
| Biological sensitization profile of patients included | With an initial biological assessment to measure specific: Immunoglobulin E (IgE) apple; rBet v 1 (PR 10 protein); rBet v 2 (profilin protein) et rPru p 3 (lipid transfer protein) | [Time Frame: Day 1] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Allergy, Apple Allergy, Oral Allergic Syndrome, Ultra-Rush, Tolerance induction, Cross-Allergy