Food Allergy in ChildrenNCT07107451
Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Allergen-specific Immunotherapy
A study testing OIT with low dose sesame protein in people with Food Allergy in Children, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients", NCT06261554. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Food Allergy in Children
- What is being tested?
- OIT with low dose sesame protein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2025to May 2029
- 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
- Sesame allergy confirmed before starting immunotherapy
- Completion of the first part of the study - achieving the maintenance dose (300mg sesame protein) during immunotherapy
- Obtaining informed consent to participate in the study,
- Patient/carer cooperation.
Who cannot join
- Severe asthma,
- Mild/moderate poorly controlled asthma: FEV1<80% (under 5. percentile), FEV1/FVC<75% (under 5. percentile), hospitalisation for asthma exacerbation in the last 12 months,
- Oral/sublingual/subcutaneous immunotherapy against other allergens in the first year/season of immunotherapy
- Eosinophilic gastroenteritis,
- Severe, recurrent episodes of anaphylaxis within the last 6 months,
- Chronic diseases requiring ongoing treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
Show all 16Show fewer
- Taking medication:
- oral, daily steroid therapy >1 month in the past 12 months,
- At least two courses of oral steroid therapy (at least 7 days) within the last 12 months,
- One oral steroid therapy (min. 7 days) in the last 3 months,
- biological treatment,
- therapy with β-blockers, ACE-inhibitors, calcium channel inhibitors,
- Pregnancy,
- No consent to participate in the study,
- Lack of cooperation from the patient.
- Well-controlled asthma, allergic rhinitis, atopic dermatitis are not considered exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Medical University of Warsaw
Warsaw, Masovian Voivodeship, 02-091
Katarzyna Grzela, MD, PhD, +48 22 3179431, katarzyna.grzela@wum.edu.pl
About this study
Official title: Evaluation of the Acquisition of Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Immunotherapy - Long-term Follow-up of Patients From the RCT Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients, NCT06261554.
This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients", NCT06261554. At the end of the original RCT all participants will undergo an open Oral Food Challenge (OFC) to assess desensitization after 3 months on the maintenance dose of OIT. Patients who have completed the first part of the study will be invited to the current part of the project:
- First arm (initial experimental group) - patients will continue oral immunotherapy (OIT) with low dose of sesame protein (300mg) for the next 8 months (+/- 3 weeks).
- Second arm (initial control group - one year on a sesame elimination diet) - patients will begin OIT following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months (+/- 3 weeks).
After an additional 8 months (+/- 3 weeks) of OIT, all study participants will undergo a 4-week cessation of treatment, followed by an open Oral Food Challenge (OFC) to assess the development of sustained unresponsiveness (SU).
Read the detailed description
Oral immunotherapy (OIT) is currently considered the most effective treatment for food allergies. The two primary goals of food immunotherapy are desensitization and sustained unresponsiveness.
Desensitization refers to the induction of temporary tolerance to the allergen, which is maintained only through regular, ongoing exposure. In contrast, the most desirable outcome-sustained unresponsiveness-is defined as the continued absence of allergic reactions to the allergen after discontinuation of immunotherapy for a specified period.
This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients", NCT06261554.
Patients who completed the initial phase will be invited to participate in the current phase of the project.
After 8 months (+/- 3 weeks) of continued OIT with a low dose of sesame protein, patients will be admitted for hospital-based assessments including skin prick testing, laboratory evaluations, and an open oral food challenge (OFC) to assess the acquisition of desensitization to sesame protein.
Patients who had a negative OFC (indicating confirmed desensitization) after 3 months of OIT during the initial phase of the study will proceed to the next part without undergoing another OFC prior to the treatment break. Only patients with confirmed desensitization, as evidenced by a negative OFC, will be eligible for the next phase.
Following a 4-week interruption in OIT, these patients will be invited for another Oral Food Challenge (OFC) to assess the acquisition of sustained unresponsiveness to sesame protein.
Patients with a positive OFC prior to the treatment break (i.e., those who did not achieve desensitization)-regardless of their original study group-will continue sesame OIT in accordance with the standard desensitization protocol used at the Clinic.
An interim analysis is planned after 50% of participants have completed the primary outcome assessment. The analysis will be conducted by an independent Data Monitoring Committee to evaluate safety and efficacy. Appropriate alpha-spending adjustments will be applied to control for Type I error.
- Conditions
- Food Allergy in Children
- Being tested
- OIT with low dose sesame protein
- Keywords
- sesame allergy, oral immunotherapy, sustained unresponsiveness (SU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OIT with low dose sesame proteinDietary supplement
After 8 months of continued low-dose sesame OIT, patients will undergo hospital-based assessments, including skin prick testing, laboratory evaluations, and an open Oral Food Challenge (OFC) to evaluate desensitization.
Patients who had a negative OFC after 3 months in the initial phase of the study-and thus confirmed desensitization-will skip the pre-break OFC and proceed directly to the next stage.
Following a 4-week interruption in OIT, patients will return for a final hospital visit, during which a concluding OFC will be conducted to assess sustained unresponsiveness. Additional laboratory tests and skin prick testing will also be performed at this visit.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance dose of sesame protein (300mg) for 8 months | Experimental | Patients assigned to the experimental group in the first part of the study (RCT) will continue OIT with the maintenance dose of sesame protein (300mg) for the next 8 months. Receives: Dietary Supplement: OIT with low dose sesame protein |
| Immunotherapy initiated after one year of sesame avoidance | Experimental | Patients assigned to the control group in the first part of the study, after one year on a sesame elimination diet, will begin immunotherapy following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months. Receives: Dietary Supplement: OIT with low dose sesame protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained unresponsiveness determined by the outcome of the OFC
Percentage of patients achieving sustained unresponsiveness after low-dose (300 mg) sesame oral immunotherapy, defined as tolerating 4 g of sesame in OFC after 4 weeks of sesame avoidance.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Secondary outcomes (16)
Changes in sesame protein tolerance during OFC
Comparison of the amount of sesame protein tolerated during each oral food challenge (OFC) by each patient. Every OFC will be performed according to PRACTALL guidelines.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Adverse event
Quantity and severity of adverse effect divided into 3 categories: mild, moderate and severe reactions.
Measured: 11 months on the maintenance dose of OIT (±3 weeks) and a 4 week break (+/- 7 days).
Quality of life - FAQLQ (Food Allergy Quality of Life Questionnaire)
Assessment of the quality of life of patients and their families before each open oral sesame protein challenge trial (impact of allergy on family life) based on the Food Allergy Quality of Life Questionnaire (FAQLQ).
Based on the FAQLQ score, quality of life will be assessed on a scale ranging from minimal to severe impairment due to food allergy.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Basophil activation test (BAT)
Assessment of CD63+ basophil marker expression prior to desensitisation and before any OFC.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness - wheal diameter in PTS
The following parameters will be assessed:
Wheal diameter in PTS after exposure to tahini and sesame extract, measured in millimeters (mm).
All outcomes will be measured before OIT, before the 4-week break, and after the 4-week break during OIT.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness - sIgE
The following parameters will be assessed:
Specific IgE concentrations to sesame extract and Ses i 1 (measured by both ALEX and ImmunoCAP) measured in kilo Units of Allergen-specific IgE per Liter (kUA/L).
All outcomes will be measured before OIT, before the 4-week break, and after the 4-week break during OIT.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness - IgG4
The following parameters will be assessed:
IgG4 levels measured in milligrams per liter (mg/L).
All outcomes will be measured before OIT, before the 4-week break, and after the 4-week break during OIT.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness - the sIgE/tIgE ratio
The following parameters will be assessed:
The sIgE/tIgE ratio.
All outcomes will be measured before OIT, before the 4-week break, and after the 4-week break during OIT.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Cut-off Values for Sustained Unresponsiveness Prediction - PTS wheal diameter
Identification of the PTS wheal diameter measured in millimeters (mm) above which the patient is unlikely to achieve sustained unresponsiveness as a result of immunotherapy.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Cut-off Values for Sustained Unresponsiveness Prediction - sIgE
Identification of the concentrations of specific IgE to sesame extract and Ses i 1 (measured by both ALEX and ImmunoCAP in kUA/L), above which the patient is unlikely to achieve sustained unresponsiveness as a result of immunotherapy.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Determination of Threshold Differences Predictive of Sustained Unresponsiveness - PTS wheal diameter
Identification of the threshold value for the change in PTS wheal diameter measured in millimeters (mm) before and after OIT, that best distinguishes patients who will achieve sustained unresponsiveness from those who will not.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Determination of Threshold Differences Predictive of Sustained Unresponsiveness - sIgE
Identification of the threshold value for the change in specific IgE to sesame extract and Ses i 1 (measured by both ALEX and ImmunoCAP in kUA/L) before and after OIT, that best distinguishes patients who will achieve sustained unresponsiveness from those who will not.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Evaluation of the Impact of Dose Escalation Duration on OIT Efficacy
Assessment of how the duration of the dose escalation phase during oral immunotherapy (OIT) impacts treatment effectiveness, measured by the number of patients achieving desensitization and/or sustained unresponsiveness.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Predictive Markers of Severe Allergic Reactions - sIgE
Evaluation of specific IgE levels to sesame extract and Ses i 1 (measured by both ALEX and ImmunoCAP in kUA/L) to assess predictive markers of severe allergic reactions.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Predictive Markers of Severe Allergic Reactions - the sIgE/tIgE ratio
Evaluation of the ratio of sIgE values to total IgE to assess predictive markers of severe allergic reactions..
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Predictive Markers of Severe Allergic Reactions - BAT
Evaluation of the basophil activation test (BAT) results (measured by %CD3+) to assess predictive markers of severe allergic reactions.
Measured: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Food Allergy in ChildrenStudies 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
- Non-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
- NCT07107451
- Sponsor's protocol ID
- KB/60/2025
- Status last verified
- Aug 2025
- First submitted
- 30 May 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the results of this study-including text, tables, figures, and appendices-will be made available upon reasonable request to the author of this protocol, subject to ethical approval and data sharing agreements.
Publications
Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed? J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):58-62.e5. doi: 10.1016/j.jaip.2016.11.009.
PubMed 28065342Sampson 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 23195525Rodriguez Del Rio P, Escudero C, Sanchez-Garcia S, Ibanez MD, Vickery BP. Evaluating primary end points in peanut immunotherapy clinical trials. J Allergy Clin Immunol. 2019 Feb;143(2):494-506. doi: 10.1016/j.jaci.2018.09.035. Epub 2018 Oct 24.
PubMed 30367908Shah A, Cox AL, Groetch M, Kattan JD, Schaible A, Sicherer SH, Tsuang A, Wang J, Oriel RC. Sesame oral immunotherapy outcomes in a pediatric cohort. J Allergy Clin Immunol Pract. 2025 Apr;13(4):938-940.e1. doi: 10.1016/j.jaip.2025.01.036. Epub 2025 Feb 8. No abstract available.
PubMed 39929303Burks AW, Sampson HA, Plaut M, Lack G, Akdis CA. Treatment for food allergy. J Allergy Clin Immunol. 2018 Jan;141(1):1-9. doi: 10.1016/j.jaci.2017.11.004.
PubMed 29307409Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.
PubMed 29205393Adatia 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 28490893Dalal 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 22610362
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Acquisition of Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Immunotherapy - Long-term Follow-up of Patients From the RCT Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients, NCT06261554.
- ClinicalTrials.gov ID
- NCT07107451
- Acronym / sponsor ID
- KB/60/2025
- Conditions
- Food Allergy in Children
- Keywords
- sesame allergy, oral immunotherapy, sustained unresponsiveness (SU)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 6 Aug 2025 (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.
This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients", NCT06261554. At the end of the original RCT all participants will undergo an open Oral Food Challenge (OFC) to assess desensitization after 3 months on the maintenance dose of OIT. Patients who have completed the first part of the study will be invited to the current part of the project:
- First arm (initial experimental group) - patients will continue oral immunotherapy (OIT) with low dose of sesame protein (300mg) for the next 8 months (+/- 3 weeks).
- Second arm (initial control group - one year on a sesame elimination diet) - patients will begin OIT following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months (+/- 3 weeks).
After an additional 8 months (+/- 3 weeks) of OIT, all study participants will undergo a 4-week cessation of treatment, followed by an open Oral Food Challenge (OFC) to assess the development of sustained unresponsiveness (SU).
Detailed description
Oral immunotherapy (OIT) is currently considered the most effective treatment for food allergies. The two primary goals of food immunotherapy are desensitization and sustained unresponsiveness.
Desensitization refers to the induction of temporary tolerance to the allergen, which is maintained only through regular, ongoing exposure. In contrast, the most desirable outcome-sustained unresponsiveness-is defined as the continued absence of allergic reactions to the allergen after discontinuation of immunotherapy for a specified period.
This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients", NCT06261554.
Patients who completed the initial phase will be invited to participate in the current phase of the project.
After 8 months (+/- 3 weeks) of continued OIT with a low dose of sesame protein, patients will be admitted for hospital-based assessments including skin prick testing, laboratory evaluations, and an open oral food challenge (OFC) to assess the acquisition of desensitization to sesame protein.
Patients who had a negative OFC (indicating confirmed desensitization) after 3 months of OIT during the initial phase of the study will proceed to the next part without undergoing another OFC prior to the treatment break. Only patients with confirmed desensitization, as evidenced by a negative OFC, will be eligible for the next phase.
Following a 4-week interruption in OIT, these patients will be invited for another Oral Food Challenge (OFC) to assess the acquisition of sustained unresponsiveness to sesame protein.
Patients with a positive OFC prior to the treatment break (i.e., those who did not achieve desensitization)-regardless of their original study group-will continue sesame OIT in accordance with the standard desensitization protocol used at the Clinic.
An interim analysis is planned after 50% of participants have completed the primary outcome assessment. The analysis will be conducted by an independent Data Monitoring Committee to evaluate safety and efficacy. Appropriate alpha-spending adjustments will be applied to control for Type I error.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance dose of sesame protein (300mg) for 8 months | Experimental | Dietary Supplement: OIT with low dose sesame proteinPatients assigned to the experimental group in the first part of the study (RCT) will continue OIT with the maintenance dose of sesame protein (300mg) for the next 8 months. |
| Immunotherapy initiated after one year of sesame avoidance | Experimental | Dietary Supplement: OIT with low dose sesame proteinPatients assigned to the control group in the first part of the study, after one year on a sesame elimination diet, will begin immunotherapy following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Sesame allergy confirmed before starting immunotherapy
- Completion of the first part of the study - achieving the maintenance dose (300mg sesame protein) during immunotherapy
- Obtaining informed consent to participate in the study,
- Patient/carer cooperation.
Key exclusion criteria (16 listed)
- Severe asthma,
- Mild/moderate poorly controlled asthma: FEV1<80% (under 5. percentile), FEV1/FVC<75% (under 5. percentile), hospitalisation for asthma exacerbation in the last 12 months,
- Oral/sublingual/subcutaneous immunotherapy against other allergens in the first year/season of immunotherapy
- Eosinophilic gastroenteritis,
- Severe, recurrent episodes of anaphylaxis within the last 6 months,
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 |
|---|---|---|
| OIT with low dose sesame proteinAfter 8 months of continued low-dose sesame OIT, patients will undergo hospital-based assessments, including skin prick testing, laboratory evaluations, and an open Oral Food Challenge (OFC) to evaluate desensitization. Patients who had a negative OFC after 3 months in the initial phase of the study-and thus confirmed desensitization-will skip the pre-break OFC and proceed directly to the next stage. Following a 4-week interruption in OIT, patients will return for a final hospital visit, during which a concluding OFC will be conducted to assess sustained unresponsiveness. Additional laboratory tests and skin prick testing will also be performed at this visit. | Dietary supplement | Immunotherapy initiated after one year of sesame avoidance, Maintenance dose of sesame protein (300mg) for 8 months |
Primary outcome
Sustained unresponsiveness determined by the outcome of the OFC
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Percentage of patients achieving sustained unresponsiveness after low-dose (300 mg) sesame oral immunotherapy, defined as tolerating 4 g of sesame in OFC after 4 weeks of sesame avoidance.
16 secondary outcomes
Changes in sesame protein tolerance during OFC
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Adverse event
Time frame: 11 months on the maintenance dose of OIT (±3 weeks) and a 4 week break (+/- 7 days).
Quality of life - FAQLQ (Food Allergy Quality of Life Questionnaire)
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Basophil activation test (BAT)
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness - wheal diameter in PTS
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness - sIgE
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness - IgG4
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness - the sIgE/tIgE ratio
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Cut-off Values for Sustained Unresponsiveness Prediction - PTS wheal diameter
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Cut-off Values for Sustained Unresponsiveness Prediction - sIgE
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Determination of Threshold Differences Predictive of Sustained Unresponsiveness - PTS wheal diameter
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Determination of Threshold Differences Predictive of Sustained Unresponsiveness - sIgE
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Evaluation of the Impact of Dose Escalation Duration on OIT Efficacy
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Predictive Markers of Severe Allergic Reactions - sIgE
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Predictive Markers of Severe Allergic Reactions - the sIgE/tIgE ratio
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Predictive Markers of Severe Allergic Reactions - BAT
Time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
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 6 Aug 2025.
- Background: PubMed 28065342Cox LS, Sanchez-Borges M, Lockey RF. World Allergy Organization Systemic Allergic Reaction Grading System: Is a Modification Needed? J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):58-62.e5. doi: 10.1016/j.jaip.2016.11.009.
- 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 30367908Rodriguez Del Rio P, Escudero C, Sanchez-Garcia S, Ibanez MD, Vickery BP. Evaluating primary end points in peanut immunotherapy clinical trials. J Allergy Clin Immunol. 2019 Feb;143(2):494-506. doi: 10.1016/j.jaci.2018.09.035. Epub 2018 Oct 24.
- Background: PubMed 39929303Shah A, Cox AL, Groetch M, Kattan JD, Schaible A, Sicherer SH, Tsuang A, Wang J, Oriel RC. Sesame oral immunotherapy outcomes in a pediatric cohort. J Allergy Clin Immunol Pract. 2025 Apr;13(4):938-940.e1. doi: 10.1016/j.jaip.2025.01.036. Epub 2025 Feb 8. No abstract available.
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- Background: PubMed 29205393Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.
- 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 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.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the results of this study-including text, tables, figures, and appendices-will be made available upon reasonable request to the author of this protocol, subject to ethical approval and data sharing agreements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OIT with low dose sesame protein in people with Food Allergy in Children, 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 4 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: opening soon, as of the sponsor's last update on 6 Aug 2025. 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, 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?
Sustained unresponsiveness determined by the outcome of the OFC (time frame: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).). 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 NCT07107451, which also lists 8 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 6 Aug 2025.