Efficacy of Oral Tolerance Induction to Raw Apple

NCT04116580 | Completed

• 1 other identifier: Apple CAB 1 - 2019
• Study Type: observational
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Food Allergy; Apple Allergy; Oral Allergic Syndrome; Ultra-Rush; Tolerance induction; Cross-Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  [Time Frame: Day 1]

• Ultra-Rush incidence on pulse rate (in bpm)

  [Time Frame: Day 1]

• Ultra-Rush incidence on peak-flow (in liters/mn)

  [Time Frame: Day 1]

• Procedure's safety on side effects according to a Visual Analogue Scale (VAS)

  [Time Frame: Day 1]

• Tolerance of apple re-consumption on a daily basis during the 2 months following ultra-rush

  [Time Frame: Day 1]

Study Arms (1)

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

Interventions

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

Allergic patients to raw apple and birch

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michel Bouvier: lead
• Polyclinique du Beaujolais: collaborator
• Clinique Charcot: collaborator

Related Publications (10)

• 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. No abstract available.

  PMID: 19958318 BACKGROUND

• 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.

  PMID: 22070352 BACKGROUND

• Werfel T, Asero R, Ballmer-Weber BK, Beyer K, Enrique E, Knulst AC, Mari A, Muraro A, Ollert M, Poulsen LK, Vieths S, Worm M, Hoffmann-Sommergruber K. Position paper of the EAACI: food allergy due to immunological cross-reactions with common inhalant allergens. Allergy. 2015 Sep;70(9):1079-90. doi: 10.1111/all.12666. Epub 2015 Jul 7.

  PMID: 26095197 BACKGROUND

• 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

  BACKGROUND

• 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, Host 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.

  PMID: 24909706 BACKGROUND

• Mauro M, Russello M, Incorvaia C, Gazzola G, Frati F, Moingeon P, Passalacqua G. Birch-apple syndrome treated with birch pollen immunotherapy. Int Arch Allergy Immunol. 2011;156(4):416-22. doi: 10.1159/000323909. Epub 2011 Aug 10.

  PMID: 21832831 BACKGROUND

• 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.

  PMID: 29130794 BACKGROUND

• 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. doi: 10.1002/mnfr.200400037.

  PMID: 15508179 BACKGROUND

• Kinaciyan T, Jahn-Schmid B, Radakovics A, Zwolfer 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. doi: 10.1016/j.jaci.2006.11.010. Epub 2007 Jan 3.

  PMID: 17204315 BACKGROUND

• Scala E, Abeni D, Guerra EC, Locanto M, Pirrotta L, Meneguzzi G, Giani M, Asero R. Cosensitization to profilin is associated with less severe reactions to foods in nsLTPs and storage proteins reactors and with less severe respiratory allergy. Allergy. 2018 Sep;73(9):1921-1923. doi: 10.1111/all.13501. Epub 2018 Jun 22. No abstract available.

  PMID: 29885248 BACKGROUND

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Bouvier Michel, MD

  Centre d' Allergologie du Beaujolais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2019
• First Posted: October 4, 2019
• Study Start: June 1, 2016
• Primary Completion: October 31, 2017
• Study Completion: October 31, 2018
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share