Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients

NCT06261554 | Recruiting

• 1 other identifier: Low-dose sesame OIT
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy.

Conditions

Food Allergy

Keywords

sesame; food allergy; immunotherapy; children

Outcome Measures

Primary Outcomes (1)

• Tolerance of sesame

  The proportion of participants who tolerate the single dose of 4000mg sesame protein at the conclusion of the study.

  Up to 18 months after starting oral immunotherapy

Secondary Outcomes (5)

• Adverse event

  Up to 18 months after starting oral immunotherapy

• Laboratory data

  Up to 18 months after starting oral immunotherapy

• Basophil activation test

  Up to 18 months after starting oral immunotherapy

• Skin prick test (SPT)

  Up to 18 months after starting oral immunotherapy

• Desensitization dose

  Up to 18 months after starting oral immunotherapy

Study Arms (2)

Sesame immunotherapy

EXPERIMENTAL

Children with sesame allergy receiving OIT.

Dietary Supplement: Dietary Supplement: Low dose OIT

Sesame avoidance

NO INTERVENTION

Children with sesame allergy not undergoing OIT.

Interventions

Dietary Supplement: Low dose OIT DIETARY_SUPPLEMENT

Following the building-up phase (up to 14 months), patients will receive a daily low dose of sesame paste (300 mg sesame protein) mixed with well-tolerated fruit mousse or bread for 3 months (12 +/- 3 weeks).

Sesame immunotherapy

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 3 and 17 years,
• IgE-mediated sesame allergy confirmed with 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),
• Allergic reaction to sesame protein during oral food challenge (OFC),
• Signed Informed Consent by parent/legal guardian and patient aged \>16 years old,
• Patient's and caregivers' cooperation with the researcher.

You may not qualify if:

• No confirmed sesame allergy,
• Negative OFC with sesame protein (maximum dose 4000mg),
• 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 allergens in the first year of immunotherapy,
• 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 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,
• any biological treatment,
• therapy with β-blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium channel inhibitors,
• Pregnancy,
• No consent to participate in the study,

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical University of Warsaw

Warsaw, Masovian Voivodeship, 02-091, Poland

RECRUITING

Related Publications (15)

• Gupta RS, Warren CM, Smith BM, Blumenstock JA, Jiang J, Davis MM, Nadeau KC. The Public Health Impact of Parent-Reported Childhood Food Allergies in the United States. Pediatrics. 2018 Dec;142(6):e20181235. doi: 10.1542/peds.2018-1235. Epub 2018 Nov 19. Erratum In: Pediatrics. 2019 Mar;143(3):e20183835. doi: 10.1542/peds.2018-3835.

  PMID: 30455345 BACKGROUND

• Warren CM, Jiang J, Gupta RS. Epidemiology and Burden of Food Allergy. Curr Allergy Asthma Rep. 2020 Feb 14;20(2):6. doi: 10.1007/s11882-020-0898-7.

  PMID: 32067114 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

• Sicherer SH, Warren CM, Dant C, Gupta RS, Nadeau KC. Food Allergy from Infancy Through Adulthood. J Allergy Clin Immunol Pract. 2020 Jun;8(6):1854-1864. doi: 10.1016/j.jaip.2020.02.010.

  PMID: 32499034 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

• Osborne NJ, Koplin JJ, Martin PE, Gurrin LC, Lowe AJ, Matheson MC, Ponsonby AL, Wake M, Tang ML, Dharmage SC, Allen KJ; HealthNuts Investigators. Prevalence of challenge-proven IgE-mediated food allergy using population-based sampling and predetermined challenge criteria in infants. J Allergy Clin Immunol. 2011 Mar;127(3):668-76.e1-2. doi: 10.1016/j.jaci.2011.01.039.

  PMID: 21377036 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

• Aaronov D, Tasher D, Levine A, Somekh E, Serour F, Dalal I. Natural history of food allergy in infants and children in Israel. Ann Allergy Asthma Immunol. 2008 Dec;101(6):637-40. doi: 10.1016/S1081-1206(10)60228-1.

  PMID: 19119709 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

• Begin P, Winterroth LC, Dominguez T, Wilson SP, Bacal L, Mehrotra A, Kausch B, Trela A, Hoyte E, O'Riordan G, Seki S, Blakemore A, Woch M, Hamilton RG, Nadeau KC. Safety and feasibility of oral immunotherapy to multiple allergens for food allergy. Allergy Asthma Clin Immunol. 2014 Jan 15;10(1):1. doi: 10.1186/1710-1492-10-1.

  PMID: 24428859 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

• Zielinska J, Zagorska W, Krupa-Laska A, Lyzwa K, Lewandowski Z, Kulus M, Grzela K. Efficacy and safety of low-dose sesame oral immunotherapy in paediatric patients: a protocol for a single-centre, randomised controlled trial. BMJ Open. 2024 Aug 12;14(8):e085811. doi: 10.1136/bmjopen-2024-085811.

  PMID: 39134434 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity; SeSAME syndrome

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Katarzyna Grzela, PhD, MD

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

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: March 14, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

PL (1)