Allergic Reaction Caused by Food (Disorder) Clinical Trial
— RAAPOfficial title:
Efficacy of Oral Tolerance Induction to Raw Apple Using an Ultra Rush Protocol in 28 Rosacea Allergic Patients
| Verified date | October 2019 |
| Source | Centre d'Allergologie du Beaujolais |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 28 |
| Est. completion date | October 31, 2018 |
| Est. primary completion date | October 31, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 10 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Michel Bouvier | Clinique Charcot, Polyclinique du Beaujolais |
Bouvier M; Van der Brempt X; Nosbaum A; Cordier JM; Nicolas JF; Berard F. Induction of oral tolerance in allergy to rosaceae. Revue Française d'Allergologie (54): 127-133, 2014
Hansen KS, Khinchi MS, Skov PS, Bindslev-Jensen C, Poulsen LK, Malling HJ. Food allergy to apple and specific immunotherapy with birch pollen. Mol Nutr Food Res. 2004 Nov;48(6):441-8. — View Citation
Incorvaia C, Ridolo E, Mauro M, Russello M, Pastorello E. Allergen immunotherapy for birch-apple syndrome: what do we know? Immunotherapy. 2017 Nov;9(15):1271-1278. doi: 10.2217/imt-2017-0040. Review. — View Citation
Kinaciyan T, Jahn-Schmid B, Radakovics A, Zwölfer B, Schreiber C, Francis JN, Ebner C, Bohle B. Successful sublingual immunotherapy with birch pollen has limited effects on concomitant food allergy to apple and the immune response to the Bet v 1 homolog Mal d 1. J Allergy Clin Immunol. 2007 Apr;119(4):937-43. Epub 2007 Jan 3. — View Citation
Kopac P, Rudin M, Gentinetta T, Gerber R, Pichler Ch, Hausmann O, Schnyder B, Pichler WJ. Continuous apple consumption induces oral tolerance in birch-pollen-associated apple allergy. Allergy. 2012 Feb;67(2):280-5. doi: 10.1111/j.1398-9995.2011.02744.x. Epub 2011 Nov 10. — View Citation
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Muraro A, Werfel T, Hoffmann-Sommergruber K, Roberts G, Beyer K, Bindslev-Jensen C, Cardona V, Dubois A, duToit G, Eigenmann P, Fernandez Rivas M, Halken S, Hickstein L, Høst A, Knol E, Lack G, Marchisotto MJ, Niggemann B, Nwaru BI, Papadopoulos NG, Poulsen LK, Santos AF, Skypala I, Schoepfer A, Van Ree R, Venter C, Worm M, Vlieg-Boerstra B, Panesar S, de Silva D, Soares-Weiser K, Sheikh A, Ballmer-Weber BK, Nilsson C, de Jong NW, Akdis CA; EAACI Food Allergy and Anaphylaxis Guidelines Group. EAACI food allergy and anaphylaxis guidelines: diagnosis and management of food allergy. Allergy. 2014 Aug;69(8):1008-25. doi: 10.1111/all.12429. Epub 2014 Jun 9. — View Citation
Nucera E, Aruanno A, Lombardo C, Patriarca G, Schiavino D. Apple desensitization in two patients with PR-10 proteins allergy. Allergy. 2010 Aug;65(8):1060-1. doi: 10.1111/j.1398-9995.2009.02275.x. Epub 2009 Dec 3. — View Citation
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patients' tolerance to Golden apple re-consumption according to a Visual Analogue Scale (VAS) | 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 | Ultra-Rush incidence on blood pressure constants (in mmHg) | Measurement of blood pressure constants during Ultra-Rush | [Time Frame: Day 1] | |
| Secondary | Ultra-Rush incidence on pulse rate (in bpm) | Measurement of pulse in beats per minute during Ultra-Rush | [Time Frame: Day 1] | |
| Secondary | Ultra-Rush incidence on peak-flow (in liters/mn) | Measurement of peak-flow in liters per minute during Ultra-Rush | [Time Frame: Day 1] | |
| Secondary | Procedure's safety on side effects according to a Visual Analogue Scale (VAS) | 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] | |
| Secondary | Tolerance of apple re-consumption on a daily basis during the 2 months following ultra-rush | 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] | |
| Secondary | 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) | 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] | |
| Secondary | Number of participants eating rosacea with no or mild OAS at 1 year | During a specific interrogation in a telephone interview | [Time Frame: Day 1] | |
| Secondary | Biological sensitization profile of patients included | 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] |