Induction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy

NCT05923216 | Enrolling By Invitation

• 1 other identifier: Sesame Protocol - SU
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is an experimental, interventional study, following on from a clinical trial comparing the efficacy and safety of oral immunotherapy with low and high doses of sesame protein, in which patient desensitisation was achieved (High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety, NCT05158413). The aim of this study is to assess a sustained unresponsiveness (SU) to sesame protein after at least 8 months of previously assigned high- or low-dose sesame OIT, followed by 4-week-allergen avoidance, and verified by an open oral food challenge (OOFC).

Conditions

Food Allergy

Keywords

sesame; food allergy; sustained unresponsiveness; children

Outcome Measures

Primary Outcomes (2)

• Sustained unresponsiveness to a sesame protein after discontinuing oral immunotherapy for 4 weeks.

  Percentage of patients tolerating their maintenance dose of sesame protein after a 4-week break in immunotherapy

  Up to 9 months after starting maintenance phase

• The highest tolerated dose of sesame protein after discontinuing oral immunotherapy for 4 weeks.

  Sustained unresponsiveness assessed as the highest tolerated dose of sesame protein at oral food challenge.

  Up to 9 months after starting maintenance phase

Secondary Outcomes (4)

• Adverse events

  Up to 9 months after starting maintenance phase

• Laboratory data

  Up to 9 months after starting maintenance phase

• Skin prick test (SPT)

  Up to 9 months after starting maintenance phase

• Tolerance of a single dose of 4000 mg of sesame protein

  Up to 9 months after starting maintenance phase

Study Arms (2)

High dose

EXPERIMENTAL

20 patients Intervention: Dietary Supplement: High dose OIT

Dietary Supplement: High dose OIT

Low dose

ACTIVE COMPARATOR

20 patients Intervention: Dietary Supplement: Low dose OIT

Dietary Supplement: Low dose OIT

Interventions

High dose OIT DIETARY_SUPPLEMENT

Patients will receive daily a high dose of the sesame paste (1200 mg sesame protein) mixed with well-tolerated fruit mousse or bread.

High dose

Low dose OIT DIETARY_SUPPLEMENT

Patients will receive daily a low dose of the sesame paste (300 mg sesame protein) mixed with well-tolerated fruit mousse or bread.

Low dose

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients who have accomplished their per-protocol participation in trial NCT05158413.
• signed Informed Consent by parent/legal guardian and patient aged\>16 years old
• patient's/caregiver's cooperation with researcher

You may not qualify if:

• severe asthma
• uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)\<80% (under 5 percentile), FEV1/forced vital capacity (FEV)\<75% (under 5 percentile), hospitalization due to asthma exacerbation within last 12 months
• current oral/sublingual/subcutaneous immunotherapy with another allergen
• eosinophilic esophagitis
• allergic reaction of 4th or higher grade according to the World Allergy Organisation Systemic Allergic Reaction Grading System during immunotherapy
• a history of severe recurrent anaphylaxis episodes
• chronic diseases requiring continous treatment, including heart disease, epilepsy, metabolic disease, diabetes
• medication:
• oral, daily steroid therapy exceeding 1 month within the last 12 months
• at least two courses of oral steroid therapy (at least 7 days) within the last 12 months
• oral steroid therapy longer than 7 days within the last 3 months
• biological treatment
• the need to constantly take antihistamines
• therapy with b-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors
• pregnancy

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw

Warsaw, 02-091, Poland

Location

Related Publications (6)

• Sampson HA, Gerth van Wijk R, Bindslev-Jensen C, Sicherer S, Teuber SS, Burks AW, Dubois AE, Beyer K, Eigenmann PA, Spergel JM, Werfel T, Chinchilli VM. Standardizing double-blind, placebo-controlled oral food challenges: American Academy of Allergy, Asthma & Immunology-European Academy of Allergy and Clinical Immunology PRACTALL consensus report. J Allergy Clin Immunol. 2012 Dec;130(6):1260-74. doi: 10.1016/j.jaci.2012.10.017. No abstract available.

  PMID: 23195525 BACKGROUND

• Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.

  PMID: 29205393 BACKGROUND

• Adatia A, Clarke AE, Yanishevsky Y, Ben-Shoshan M. Sesame allergy: current perspectives. J Asthma Allergy. 2017 Apr 27;10:141-151. doi: 10.2147/JAA.S113612. eCollection 2017.

  PMID: 28490893 BACKGROUND

• Burks AW, Sampson HA, Plaut M, Lack G, Akdis CA. Treatment for food allergy. J Allergy Clin Immunol. 2018 Jan;141(1):1-9. doi: 10.1016/j.jaci.2017.11.004.

  PMID: 29307409 BACKGROUND

• Nachshon L, Goldberg MR, Levy MB, Appel MY, Epstein-Rigbi N, Lidholm J, Holmqvist M, Katz Y, Elizur A. Efficacy and Safety of Sesame Oral Immunotherapy-A Real-World, Single-Center Study. J Allergy Clin Immunol Pract. 2019 Nov-Dec;7(8):2775-2781.e2. doi: 10.1016/j.jaip.2019.05.031. Epub 2019 May 29.

  PMID: 31150789 BACKGROUND

• Dalal I, Goldberg M, Katz Y. Sesame seed food allergy. Curr Allergy Asthma Rep. 2012 Aug;12(4):339-45. doi: 10.1007/s11882-012-0267-2.

  PMID: 22610362 BACKGROUND

MeSH Terms

Conditions

Food Hypersensitivity; SeSAME syndrome

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Katarzyna Grzela, PhD, MD

  Medical University of Warsaw

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 28, 2023
• Study Start: March 24, 2023
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)