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Completed

NCT Number: NCT04116580

Efficacy of Oral Tolerance Induction to Raw Apple

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.

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Key information

Conditions

Oral Allergic Syndrome Allergic Reaction Caused by Food (Disorder) Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Primary outcomes

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

    Time frame: [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.

Secondary outcomes

  1. Ultra-Rush incidence on blood pressure constants (in mmHg)

    Time frame: [Time Frame: Day 1]

    Measurement of blood pressure constants during Ultra-Rush

  2. Ultra-Rush incidence on pulse rate (in bpm)

    Time frame: [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: [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: [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: [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: [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: [Time Frame: Day 1]

    During a specific interrogation in a telephone interview

  8. Biological sensitization profile of patients included

    Time frame: [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)

Sponsors and collaborators

Lead sponsor

Michel Bouvier

Network

Collaborators

  • Clinique Charcot
  • Polyclinique du Beaujolais

Registry information

Official study title

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

Acronym: RAAP

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Oct 4, 2019
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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