Abstract

Background

Peanuts (PN) and tree nuts (TN) are among the most frequent elicitors of food allergy and can lead to life-threatening reactions. The current advice for allergic patients is to strictly avoid the offending food independently of their individual threshold level, whereas sensitized patients without allergic symptoms should frequently consume the food to avoid (re-)development of food allergy. The aim of this trial is to investigate (I) whether the consumption of low allergen amounts below the individual threshold may support natural tolerance development and (II) to what extent regular allergen consumption in sensitized but tolerant subjects prevents the (re-)development of PN or TN allergy.

Methods

The TINA trial consisting of (part I) a randomized, controlled, open, parallel group, single-center, superiority trial (RCT), and (part II) a prospective observational exploratory cohort study. Children and adults (age 1–67 years) with suspected or known primary PN and/or TN allergy will undergo an oral food challenge (OFC) to determine their clinical reactivity and individual threshold. In the RCT, 120 PN or TN allergic patients who tolerate ≥100 mg of food protein will be randomized (1:1 ratio) to consumption of products with low amounts of PN or TN on a regular basis or strict avoidance for 1 year. The consumption group will start with 1/100 of their individual threshold, increasing the protein amount to 1/50 and 1/10 after 4 and 8 months, respectively. The primary endpoint is the clinical tolerance to PN or TN after 1 year assessed by OFC. In the cohort study, 120 subjects sensitized to PN and/or TN but tolerant are advised to regularly consume the food and observed for 1 year. The primary endpoint is the maintenance of clinical tolerance to PN and/or TN after 1 year assessed by challenging with the former tolerated cumulative dose.

Discussion

This clinical trial will help to determine the impact of allergen consumption versus avoidance on natural tolerance development and whether the current dietary advice for PN or TN allergic patients with higher threshold levels is still valid.

Trial registration

German Clinical Trials Register; ID: DRKS00016764 (RCT), DRKS00020467 (cohort study). Registered on 15 January 2020, http://www.drks.de.

Details

Title
Tolerance induction through non-avoidance to prevent persistent food allergy (TINA) in children and adults with peanut or tree nut allergy: rationale, study design and methods of a randomized controlled trial and observational cohort study
Author
Trendelenburg, Valérie 1 ; Dölle-Bierke, Sabine 2 ; Unterleider, Nathalie 1 ; Alexiou, Aikaterina 2 ; Kalb, Birgit 1 ; Meixner, Lara 1 ; Heller, Stephanie 1 ; Lau, Susanne 1 ; Lee, Young- Ae 3 ; Fauchère, Florent 4 ; Braun, Julian 4 ; Babina, Magda 2 ; Altrichter, Sabine 5 ; Birkner, Till 6 ; Roll, Stephanie 7 ; Dobbertin-Welsch, Josefine 1 ; Worm, Margitta 2 ; Beyer, Kirsten 1   VIAFID ORCID Logo 

1  Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Berlin, Germany (GRID:grid.6363.0) (ISNI:0000 0001 2218 4662) 
2  Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu, Division of Allergy and Immunology, Department of Dermatology, Venerology and Allergy, Berlin, Germany (GRID:grid.6363.0) (ISNI:0000 0001 2218 4662) 
3  Max Delbrück Center For Molecular Medicine in the Helmholtz Association, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany (GRID:grid.6363.0) (ISNI:0000 0001 2218 4662) 
4  Si-M / “Der Simulierte Mensch” a science framework of Technische Universität Berlin and Charité - Universitätsmedizin Berlin, Berlin, Germany (GRID:grid.6363.0) (ISNI:0000 0001 2218 4662); Berlin Institute of Health at Charité - Universitätsmedizin Berlin, BIH Center for Regenerative Therapies, Berlin, Germany (GRID:grid.484013.a) (ISNI:0000 0004 6879 971X) 
5  Division of Dermatological Allergy, Department of Dermatology, Venerology and Allergy, Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany (GRID:grid.6363.0) (ISNI:0000 0001 2218 4662); Universitätsklinikum für Dermatologie und Venerologie, Kepler Uniklinikum, Linz, Austria (GRID:grid.6363.0) 
6  Experimental and Clinical Research Center, a cooperation between the Max-Delbrück-Center for Molecular Medicine in the Helmholtz Association and the Charité - Universitätsmedizin, Berlin, Germany (GRID:grid.419491.0) (ISNI:0000 0001 1014 0849); Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Experimental and Clinical Research Center, Berlin, Germany (GRID:grid.6363.0) (ISNI:0000 0001 2218 4662) 
7  Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute for Epidemiology, Social Medicine and Health Economics, Berlin, Germany (GRID:grid.6363.0) (ISNI:0000 0001 2218 4662) 
Pages
236
Publication year
2022
Publication date
Dec 2022
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-022-06149-4
ProQuest document ID
2730331131
Copyright
© The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.