Efficacy of Oral Tolerance Induction to Raw Apple (RAAP)

Michel Bouvier

Status: Completed

Conditions: Oral Allergic Syndrome; Allergic Reaction Caused by Food (Disorder)

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

Study type: Observational

Funder types: NETWORK; Other

Identifiers

NCT04116580

Apple CAB 1 - 2019

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 28 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

28 participants in 1 patient group

Allergic patients to raw apple and birch

Description:

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.

Treatment:

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