High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety

NCT05158413 | Recruiting DMC

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

Brief Summary

In this trial the investigators aim to assess the effectiveness and safety of oral immunotherapy with sesame protein in high and low dose (300mg versus 1200mg) in children with sesame allergy.

Conditions

Food Allergy

Keywords

sesame; food allergy; immunotherapy; children

Outcome Measures

Primary Outcomes (1)

• Tolerance of sesame

  Proportion of participants who tolerate the single dose of 4000mg sesame protein

  Up to 16 months after starting oral immunotherapy

Secondary Outcomes (5)

• Adverse event

  Up to 16 months after starting oral immunotherapy

• Laboratory data

  Up to 16 months after starting oral immunotherapy

• Basophil activation test

  Up to 16 months after starting oral immunotherapy

• Skin prick test (SPT)

  Up to 16 months after starting oral immunotherapy

• Desensitization dose

  Up to 16 months after starting oral immunotherapy

Study Arms (2)

High dose

EXPERIMENTAL

Experimental: high dose of sesame 20 patients

Dietary Supplement: High dose

Low dose

ACTIVE COMPARATOR

Active Comparator: low dose of sesame 20 patients

Dietary Supplement: Low dose

Interventions

High dose DIETARY_SUPPLEMENT

Patients will receive a high dose of sesame paste or flour (1200 mg of sesame protein) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product

High dose

Low dose DIETARY_SUPPLEMENT

Patients will receive a low dose of sesame paste or flour (300 mg of sesame protein) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product

Low dose

Eligibility Criteria

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

You may qualify if:

• medical history of sesame allergy,
• IgE-mediated sesame allergy confirmed as positive skin prick tests with sesame allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater than 0.35 kilo units of Allergen per liter (kUA/l) (UniCAP method),
• reaction to sesame protein during OOFC (maximum dose 4000g),
• signed Informed Consent by parent/legal guardian and patient aged \>16 years old,
• patient's/caregivers' cooperation with researcher.

You may not qualify if:

• no confirmed sesame allergy,
• negative oral food challenge with sesame protein (maximum dose 4000g),
• severe asthma,
• uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)\<80% (under 5. percentile), FEV1/forced vital capacity (FVC)\<75% (under 5. percentile), hospitalization due to asthma exacerbation within last 12 months,
• current oral/sublingual/subcutaneous immunotherapy with other allergen,
• eosinophilic gastroenteritis,
• a history of severe recurrent anaphylaxis episodes,
• chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
• medication:
• oral, daily steroid therapy longer than 1 month within last 12 months,
• at least two courses of oral steroid therapy (at least 7 days) within last 12 months,
• oral steroid therapy longer than 7 days within last 3 months,
• biological treatment,
• the need to constantly take antihistamines,
• therapy with β-blockers, angiotensin converting enzyme (ACE) inhibitors, calcium channel inhibitors,

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Katarzyna Grzela

Warsaw, 02-091, Poland

RECRUITING

Related Publications (9)

• Gupta RS, Warren CM, Smith BM, et al. The Public Health Impact of Parent-Reported Childhood Food Allergies in the United States. Pediatrics. 2018:142(6):e20181235. Pediatrics. 2019 Mar;143(3):e20183835. doi: 10.1542/peds.2018-3835. No abstract available.

  PMID: 30819972 BACKGROUND

• Gupta RS, Warren CM, Smith BM, Jiang J, Blumenstock JA, Davis MM, Schleimer RP, Nadeau KC. Prevalence and Severity of Food Allergies Among US Adults. JAMA Netw Open. 2019 Jan 4;2(1):e185630. doi: 10.1001/jamanetworkopen.2018.5630.

  PMID: 30646188 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

• Warren CM, Chadha AS, Sicherer SH, Jiang J, Gupta RS. Prevalence and Severity of Sesame Allergy in the United States. JAMA Netw Open. 2019 Aug 2;2(8):e199144. doi: 10.1001/jamanetworkopen.2019.9144.

  PMID: 31373655 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

• 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

• Brough HA, Caubet JC, Mazon A, Haddad D, Bergmann MM, Wassenberg J, Panetta V, Gourgey R, Radulovic S, Nieto M, Santos AF, Nieto A, Lack G, Eigenmann PA. Defining challenge-proven coexistent nut and sesame seed allergy: A prospective multicenter European study. J Allergy Clin Immunol. 2020 Apr;145(4):1231-1239. doi: 10.1016/j.jaci.2019.09.036. Epub 2019 Dec 20.

  PMID: 31866098 BACKGROUND

• 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

• Feuille E, Nowak-Wegrzyn A. Allergen-Specific Immunotherapies for Food Allergy. Allergy Asthma Immunol Res. 2018 May;10(3):189-206. doi: 10.4168/aair.2018.10.3.189.

  PMID: 29676066 BACKGROUND

MeSH Terms

Conditions

Food Hypersensitivity; SeSAME syndrome

Interventions

Contraceptives, Oral

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Katarzyna Grzela, MD, PhD

  Medical University of Warsaw

  STUDY CHAIR

Central Study Contacts

Katarzyna Grzela, MD, PhD

CONTACT

+48 22 3179431; katarzyna.grzela@wum.edu.pl

Joanna Zielińska, MD

CONTACT

joanna_zielinska@outlook.com

Study Design

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

Model Details: Participants will be randomly assigned to two groups. During the maintenance phase, the first group will receive low dose of sesame protein, which amounts 300mg, the second will get high dose, which is 1200 mg of sesame protein. Oral immunotherapy with low (300mg) and high (1200mg) dose of sesame protein in children randomly assigned to two groups (1:1). Patients will receive ground sesame mixed with apple mousse (supposing apple tolerance). For the transparency of the study all patients will receive the same commercially prepared apple muss product.

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 15, 2021
• Study Start: March 31, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)