Efficacy of Oral Tolerance Induction to Raw Apple

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EstadoTerminado

Patrocinadores

Michel Bouvier

Colaboradores

Polyclinique du Beaujolais

Clinique Charcot

ENSAYO CLÍNICO: NCT04116580

BioSeek: NCT04116580

Palabras clave

Abstracto

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.

Descripción

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.

fechas

Verificado por última vez:	09/30/2019
Primero enviado:	08/10/2019
Inscripción estimada enviada:	10/02/2019
Publicado por primera vez:	10/03/2019
Última actualización enviada:	10/03/2019
Última actualización publicada:	10/07/2019
Fecha de inicio real del estudio:	05/31/2016
Fecha estimada de finalización primaria:	10/30/2017
Fecha estimada de finalización del estudio:	10/30/2018

Condición o enfermedad

Oral Allergic Syndrome

Allergic Reaction Caused by Food (Disorder)

Intervención / tratamiento

Other: Allergic patients to raw apple and birch

Fase

Grupos de brazos

Brazo	Intervención / tratamiento
Allergic patients to raw apple and birch 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: Allergic patients to raw apple and birch

Criterio de elegibilidad

Edades elegibles para estudiar	10 Years A 10 Years
Sexos elegibles para estudiar	All
Método de muestreo	Non-Probability Sample
Acepta voluntarios saludables	si
Criterios	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

Salir

Medidas de resultado primarias

1. Patients' tolerance to Golden apple re-consumption according to a Visual Analogue Scale (VAS) [[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.

Medidas de resultado secundarias

1. Ultra-Rush incidence on blood pressure constants (in mmHg) [[Time Frame: Day 1]]

Measurement of blood pressure constants during Ultra-Rush

2. Ultra-Rush incidence on pulse rate (in bpm) [[Time Frame: Day 1]]

Measurement of pulse in beats per minute during Ultra-Rush

3. Ultra-Rush incidence on peak-flow (in liters/mn) [[Time Frame: Day 1]]

Measurement of peak-flow in liters per minute during Ultra-Rush

4. Procedure's safety on side effects according to a Visual Analogue Scale (VAS) [[Time Frame: Day 1]]

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.

5. Tolerance of apple re-consumption on a daily basis during the 2 months following ultra-rush [[Time Frame: Day 1]]

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)

6. 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]]

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).

7. Number of participants eating rosacea with no or mild OAS at 1 year [[Time Frame: Day 1]]

During a specific interrogation in a telephone interview

8. Biological sensitization profile of patients included [[Time Frame: Day 1]]

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)

Efficacy of Oral Tolerance Induction to Raw Apple

Palabras clave

lilium carniolicum

hipersensibilidad

rosácea

lilium