Clinical trial NCT04116580: Efficacy of Oral Tolerance Induction to Raw Apple
Official title: Efficacy of Oral Tolerance Induction to Raw Apple Using an Ultra Rush Protocol in 28 Rosacea Allergic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Allergic Syndrome
Allergic Reaction Caused by Food (Disorder)
Keywords: Food Allergy
Apple Allergy
Oral Allergic Syndrome
Ultra-Rush
Tolerance induction
Cross-Allergy
Lead sponsor: Centre d'Allergologie du Beaujolais
Sponsor class: NETWORK
Collaborators: name: Polyclinique du Beaujolais
name: Clinique Charcot
First posted: 2019-10-04
Enrollment: 28
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Food-Pollen Allergic patients aged 10 years and more, allergic to birch pollen and not eating any more rosacee for at least 6 months

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patients' tolerance to Golden apple re-consumption according to a Visual Analogue Scale (VAS)
timeFrame: [Time Frame: Day 1]
Secondary outcomes:
measure: Ultra-Rush incidence on blood pressure constants (in mmHg)
timeFrame: [Time Frame: Day 1]
measure: Ultra-Rush incidence on pulse rate (in bpm)
timeFrame: [Time Frame: Day 1]
measure: Ultra-Rush incidence on peak-flow (in liters/mn)
timeFrame: [Time Frame: Day 1]
measure: Procedure's safety on side effects according to a Visual Analogue Scale (VAS)
timeFrame: [Time Frame: Day 1]
measure: Tolerance of apple re-consumption on a daily basis during the 2 months following ultra-rush
timeFrame: [Time Frame: Day 1]
measure: 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)
timeFrame: [Time Frame: Day 1]
measure: Number of participants eating rosacea with no or mild OAS at 1 year
timeFrame: [Time Frame: Day 1]
measure: Biological sensitization profile of patients included
timeFrame: [Time Frame: Day 1]
Other outcomes:
Locations:
Study officials:
affiliation: Centre d' Allergologie du Beaujolais
name: Bouvier Michel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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