Food AllergyNCT06261554
Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients
A study testing Dietary Supplement: Low dose OIT in people with Food Allergy, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Dietary Supplement: Low dose OIT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 sitePoland
- Study dates
- 14 Mar 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Joanna Zielińska, MD contact
Poland1 site, 1 recruiting
- Recruiting
Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091
Katarzyna Grzela, PhD, MD, +48 22 3179431, katarzyna.grzela@wum.edu.pl
About this study
Official title: Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Food Allergy
- Being tested
- Dietary Supplement: Low dose OIT
- 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.
Dietary Supplement: Low dose OITDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Sesame immunotherapy | Experimental | Children with sesame allergy receiving OIT. Receives: Dietary Supplement: Dietary Supplement: Low dose OIT |
| Sesame avoidance | No intervention | Children with sesame allergy not undergoing OIT. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of sesame
The proportion of participants who tolerate the single dose of 4000mg sesame protein at the conclusion of the study.
Measured: Up to 18 months after starting oral immunotherapy
Secondary outcomes (5)
Adverse event
Quantity and severity of adverse effect, assessed and compared between groups, divided into 3 categories: mild, moderate and severe reactions
Measured: Up to 18 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 18 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 18 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 18 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 18 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 Feb 2024
- Study start14 Mar 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261554
- Sponsor's protocol ID
- Low-dose sesame OIT
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices)
Publications
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.
PubMed 30455345Warren 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.
PubMed 32067114Gupta 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 30646188Sicherer 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.
PubMed 32499034Dalal 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 22610362Osborne 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.
PubMed 21377036Warren 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 31373655Aaronov 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.
PubMed 19119709Nachshon 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 31150789Begin 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.
PubMed 24428859Adatia 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 29676066Zielinska 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.
PubMed 39134434
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06261554
- Acronym / sponsor ID
- Low-dose sesame OIT
- Conditions
- Food Allergy
- Keywords
- sesame, food allergy, immunotherapy, children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 15 Feb 2024 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sesame immunotherapy | Experimental | Dietary Supplement: Dietary Supplement: Low dose OITChildren with sesame allergy receiving OIT. |
| Sesame avoidance | No intervention | –Children with sesame allergy not undergoing OIT. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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,
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 |
|---|---|---|
| Dietary Supplement: Low dose OITFollowing 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). | Dietary supplement | Sesame immunotherapy |
Primary outcome
Tolerance of sesame
Time frame: Up to 18 months after starting oral immunotherapy
The proportion of participants who tolerate the single dose of 4000mg sesame protein at the conclusion of the study.
5 secondary outcomes
Adverse event
Time frame: Up to 18 months after starting oral immunotherapy
Laboratory data
Time frame: Up to 18 months after starting oral immunotherapy
Basophil activation test
Time frame: Up to 18 months after starting oral immunotherapy
Skin prick test (SPT)
Time frame: Up to 18 months after starting oral immunotherapy
Desensitization dose
Time frame: Up to 18 months after starting oral immunotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Background: PubMed 30455345Gupta 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.
- Background: PubMed 32067114Warren 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.
- 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 32499034Sicherer 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.
- 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 21377036Osborne 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.
- 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 19119709Aaronov 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.
- 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 24428859Begin 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.
- 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices)
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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.
Joanna Zielińska, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement: Low dose OIT 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 16 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: looking for participants now, as of the sponsor's last update on 20 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Grzela, PhD, MD (+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 18 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 NCT06261554, which also lists 15 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 May 2024.