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

Food Allergy Clinical Trial

Official title:

Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261554
• Other study ID #: Low-dose sesame OIT
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2024
• Est. completion date: March 1, 2027

Study information

• Verified date: February 2024
• Source: Medical University of Warsaw
• Contact: Katarzyna Grzela, PhD, MD
• Phone: +48 22 3179431
• Email: katarzyna.grzela[@]wum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Allergic reactions to sesame can be severe and life-threatening, making it challenging to avoid hidden sources of the allergen.

This pilot study is a randomized controlled trial evaluating the efficacy and safety of oral immunotherapy (OIT) with a low-dose sesame protein in pediatric patients with sesame allergy. The study aims to compare participants undergoing OIT with a maintenance dose of 300mg sesame protein against a control group in a 2:1 randomized allocation. The control group will be recommended a standard treatment, which is a restrictive elimination diet and the use of emergency treatment, including adrenaline, in case of accidental exposure to sesame.

39 participants aged 3-17 with confirmed IgE-mediated sesame allergy will be enrolled into the study. Interventions will be administered once daily for up to 18 months, and the control group will stay under observation for one year.

Primary outcomes include the proportion of participants tolerating a single dose of 4000mg sesame protein during the final oral food challenge. Secondary outcomes assess adverse events, changes in immunological parameters, and the maximum tolerated doses of sesame protein in each group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 39
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 ß-blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium channel inhibitors,

• Pregnancy,

• No consent to participate in the study,

• Lack of patient or caregiver cooperation.

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity

Intervention

Dietary Supplement:
• Dietary Supplement: Low dose OIT
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).

Locations

Country	Name	City	State
Poland	Medical University of Warsaw	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. Erratum In: Allergy Asthma Clin Immunol. 2016;12:28. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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): — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse event	Quantity and severity of adverse effect, assessed and compared between groups, divided into 3 categories: mild, moderate and severe reactions	Up to 18 months after starting oral immunotherapy
Secondary	Laboratory data	Difference in sesame serum immunoglobulin E (IgE) level and immunoglobulin G4 (IgG4) level, compared between groups at the end of treatment.	Up to 18 months after starting oral immunotherapy
Secondary	Basophil activation test	The basophil activation test (BAT) results compared between groups at the end of treatment.	Up to 18 months after starting oral immunotherapy
Secondary	Skin prick test (SPT)	Change in skin prick test reactivity to sesame protein from baseline to end of treatment, compared between groups.	Up to 18 months after starting oral immunotherapy
Secondary	Desensitization dose	Change in maximum tolerated dose of sesame in oral food challenge before and in the end of treatment, compared between groups.	Up to 18 months after starting oral immunotherapy