Efficacy of Oral Tolerance Induction to Raw Apple (RAAP)

October 4, 2019 updated by: Michel Bouvier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

28

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
[Time Frame: Day 1]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultra-Rush incidence on blood pressure constants (in mmHg)
Time Frame: [Time Frame: Day 1]
Measurement of blood pressure constants during Ultra-Rush
[Time Frame: Day 1]
Ultra-Rush incidence on pulse rate (in bpm)
Time Frame: [Time Frame: Day 1]
Measurement of pulse in beats per minute during Ultra-Rush
[Time Frame: Day 1]
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
[Time Frame: Day 1]
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.
[Time Frame: Day 1]
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)
[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)
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).
[Time Frame: Day 1]
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
[Time Frame: Day 1]
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)
[Time Frame: Day 1]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michel Bouvier

Collaborators

Clinique Charcot
Polyclinique du Beaujolais

Investigators

  • Principal Investigator: Bouvier Michel, MD, Centre d' Allergologie du Beaujolais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

August 11, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (Actual)

October 4, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2019

Last Update Submitted That Met QC Criteria

October 4, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Apple CAB 1 - 2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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