High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety (Sesame)
March 18, 2024 updated by: Medical University of Warsaw
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Sesame allergy is an important global clinical problem affecting 0,2-0,8% population. In food allergy, allergen avoidance and emergency treatment are still therapeutic hallmarks. Oral and sublingual allergen-specific immunotherapies have been provided as a new approach to managing food allergy. The main goal of oral immunotherapy is to obtain the desensitization to food. The oral immunotherapy (OIT) is considered as safe and highly effective, according to current research. In addition, this type of therapy reduce the influence of food allergy in patient's live.
Children 4 to 17 years old with sesame allergy will be enrolled into study. Skin prick test with condiment made from toasted ground hulled sesame and open oral food challenge (OOFC) will be performed at the baseline and at the end of procedure. Blood will be analyzed for specific IgE, IgG4 levels and basophil activation test before and after OIT. OIT will consisted of two parts: dosage increase phase and maintenance phase. The Participants will be randomized (1:1) to receive sesame OIT with maintenance dose of 300 mg or 1200 mg sesame protein.
In the dosage increase phase, the dose of condiment made from toasted ground hulled sesame will be gradually increased every two weeks and administrated to a child during hospitalization (1-day procedure). Precondition to increase of dose is good tolerance of previous portion of condiment made from toasted ground hulled sesame. The maximum time frame for this phase is 14 months.
After achieving tolerance, immunotherapy will be continued for 3 months in maintenance phase, with dose 300mg or 1200 mg sesame protein. Maintenance dose is determined by random patients' assignment to one from study's .
After 3 months (12 weeks +/-2 weeks) of maintenance dose the final OOFC and evaluation of desensitization of sesame protein will be performed. Confirmation of the total desensitization to sesame is the tolerance of a single dose of 4000 mg sesame protein.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katarzyna Grzela, MD, PhD
- Phone Number: +48 22 3179431
- Email: katarzyna.grzela@wum.edu.pl
Study Contact Backup
- Name: Joanna Zielińska, MD
- Email: joanna_zielinska@outlook.com
Study Locations
-
-
-
Warsaw, Poland, 02-091
- Recruiting
- Katarzyna Grzela
-
Contact:
- Joanna Zielińska, MD
- Email: joanna_zielinska@outlook.com
-
Contact:
- Katarzyna Grzela, PhD, MD
- Phone Number: +48223179431
- Email: katarzyna.grzela@wum.edu.pl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- pregnancy,
- no consent to participate in the study,
- lack of patient cooperation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High dose
Experimental: high dose of sesame 20 patients
|
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
|
|
Active Comparator: Low dose
Active Comparator: low dose of sesame 20 patients
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tolerance of sesame
Time Frame: Up to 16 months after starting oral immunotherapy
|
Proportion of participants who tolerate the single dose of 4000mg sesame protein
|
Up to 16 months after starting oral immunotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse event
Time Frame: Up to 16 months after starting oral immunotherapy
|
Quantity and severity of adverse effect, assessed and compared between groups, divided into mild, moderate and severe category
|
Up to 16 months after starting oral immunotherapy
|
|
Laboratory data
Time Frame: Up to 16 months after starting oral immunotherapy
|
Difference in sesame serum immunoglobulin E (IgE) level and immunoglobulin G4 (IgG4) level, compared between groups at the end of treatment
|
Up to 16 months after starting oral immunotherapy
|
|
Basophil activation test
Time Frame: Up to 16 months after starting oral immunotherapy
|
The basophil activation test (BAT) results compared between groups at the end of treatment
|
Up to 16 months after starting oral immunotherapy
|
|
Skin prick test (SPT)
Time Frame: Up to 16 months after starting oral immunotherapy
|
Change in skin prick test reactivity to sesame protein from baseline to end of treatment, compared between groups
|
Up to 16 months after starting oral immunotherapy
|
|
Desensitization dose
Time Frame: Up to 16 months after starting oral immunotherapy
|
Change in maximum tolerated dose of sesame in oral food challenge before and in the end of treatment, compared between groups
|
Up to 16 months after starting oral immunotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Katarzyna Grzela, MD, PhD, Medical University of Warsaw
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 31, 2022
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
November 24, 2021
First Submitted That Met QC Criteria
December 14, 2021
First Posted (Actual)
December 15, 2021
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 18, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sesame Protocol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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