Food AllergySesameNCT05158413
High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety
A study testing High dose and Low dose in people with Food Allergy, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- High dose and Low dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 31 Mar 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Joanna Zielińska, MD contact
Poland1 site, 1 recruiting
- Recruiting
Katarzyna Grzela
Warsaw, 02-091
Katarzyna Grzela, PhD, MD, +48223179431, katarzyna.grzela@wum.edu.pl
Joanna Zielińska, MD, joanna_zielinska@outlook.com
About this study
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.
Read the 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.
- Conditions
- Food Allergy
- Being tested
- High dose, Low dose
- Keywords
- sesame, food allergy, immunotherapy, children
- Medical subject headings
- Food Hypersensitivity, SeSAME syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High doseDietary 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
Low doseDietary 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
| Study group | Role | What they receive |
|---|---|---|
| High dose | Experimental | Experimental: high dose of sesame 20 patients Receives: Dietary Supplement: High dose |
| Low dose | Active comparator | Active Comparator: low dose of sesame 20 patients Receives: Dietary Supplement: Low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of sesame
Proportion of participants who tolerate the single dose of 4000mg sesame protein
Measured: Up to 16 months after starting oral immunotherapy
Secondary outcomes (5)
Adverse event
Quantity and severity of adverse effect, assessed and compared between groups, divided into mild, moderate and severe category
Measured: Up to 16 months after starting oral immunotherapy
Laboratory data
Difference in sesame serum immunoglobulin E (IgE) level and immunoglobulin G4 (IgG4) level, compared between groups at the end of treatment
Measured: Up to 16 months after starting oral immunotherapy
Basophil activation test
The basophil activation test (BAT) results compared between groups at the end of treatment
Measured: Up to 16 months after starting oral immunotherapy
Skin prick test (SPT)
Change in skin prick test reactivity to sesame protein from baseline to end of treatment, compared between groups
Measured: Up to 16 months after starting oral immunotherapy
Desensitization dose
Change in maximum tolerated dose of sesame in oral food challenge before and in the end of treatment, compared between groups
Measured: Up to 16 months after starting oral immunotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start31 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katarzyna Grzela, MD, PhD, Study chair, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158413
- Sponsor's protocol ID
- Sesame Protocol
- Acronym
- Sesame
- Status last verified
- Mar 2024
- First submitted
- 24 Nov 2021
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30819972Gupta 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.
PubMed 30646188Dalal 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.
PubMed 22610362Warren 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.
PubMed 31373655Nachshon 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.
PubMed 31150789Adatia 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.
PubMed 28490893Brough 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.
PubMed 31866098Sampson 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.
PubMed 23195525Feuille 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.
PubMed 29676066
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety
- ClinicalTrials.gov ID
- NCT05158413
- Acronym / sponsor ID
- Sesame / Sesame Protocol
- Conditions
- Food Allergy
- Keywords
- sesame, food allergy, immunotherapy, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| High dose | Experimental | Dietary Supplement: High doseExperimental: high dose of sesame 20 patients |
| Low dose | Active comparator | Dietary Supplement: Low doseActive Comparator: low dose of sesame 20 patients |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High dosePatients 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 | Dietary supplement | High dose |
| Low dosePatients 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 | Dietary supplement | Low dose |
Primary outcome
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
5 secondary outcomes
Adverse event
Time frame: Up to 16 months after starting oral immunotherapy
Laboratory data
Time frame: Up to 16 months after starting oral immunotherapy
Basophil activation test
Time frame: Up to 16 months after starting oral immunotherapy
Skin prick test (SPT)
Time frame: Up to 16 months after starting oral immunotherapy
Desensitization dose
Time frame: Up to 16 months after starting oral immunotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 30819972Gupta 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.
- Background: PubMed 30646188Gupta 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.
- Background: PubMed 22610362Dalal 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.
- Background: PubMed 31373655Warren 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.
- Background: PubMed 31150789Nachshon 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.
- Background: PubMed 28490893Adatia 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.
- Background: PubMed 31866098Brough 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.
- Background: PubMed 23195525Sampson 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.
- Background: PubMed 29676066Feuille 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Zielińska, MD contact
Katarzyna Grzela, MD, PhD study chair
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose and Low dose in people with Food Allergy, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Grzela, MD, PhD (+48 22 3179431, katarzyna.grzela@wum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of sesame (time frame: Up to 16 months after starting oral immunotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05158413, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.