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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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).

Первичные конечные точки

• Tolerance of sesame [Срок оценки: Up to 18 months after starting oral immunotherapy]

Вторичные конечные точки (5)

• Adverse event [Срок оценки: Up to 18 months after starting oral immunotherapy]
• Laboratory data [Срок оценки: Up to 18 months after starting oral immunotherapy]
• Basophil activation test [Срок оценки: Up to 18 months after starting oral immunotherapy]
• Skin prick test (SPT) [Срок оценки: Up to 18 months after starting oral immunotherapy]
• Desensitization dose [Срок оценки: Up to 18 months after starting oral immunotherapy]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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,
• Lack of patient or caregiver cooperation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Польша · 1 центр

• Medical University of Warsaw — Warsaw

Публикации

• 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. PMID 30455345
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06261554 · Low-dose sesame OIT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗