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Food AllergyNCT05923216

Induction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy

A study testing High dose OIT and Low dose OIT in people with Food Allergy, run by Medical University of Warsaw at 1 site in Poland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This is an experimental, interventional study, following on from a clinical trial comparing the efficacy and safety of oral immunotherapy with low and high doses of sesame protein, in which patient desensitisation was achieved (High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety… 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 OIT and Low dose OIT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePoland
Study dates
24 Mar 2023to Mar 2026
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 4 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • patients who have accomplished their per-protocol participation in trial NCT05158413.
  • signed Informed Consent by parent/legal guardian and patient aged>16 years old
  • patient's/caregiver's cooperation with researcher

Who cannot join

  • severe asthma
  • uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)<80% (under 5 percentile), FEV1/forced vital capacity (FEV)<75% (under 5 percentile), hospitalization due to asthma exacerbation within last 12 months
  • current oral/sublingual/subcutaneous immunotherapy with another allergen
  • eosinophilic esophagitis
  • allergic reaction of 4th or higher grade according to the World Allergy Organisation Systemic Allergic Reaction Grading System during immunotherapy
  • a history of severe recurrent anaphylaxis episodes
Show all 17Show fewer
  • chronic diseases requiring continous treatment, including heart disease, epilepsy, metabolic disease, diabetes
  • medication:
  • oral, daily steroid therapy exceeding 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
  • biological treatment
  • the need to constantly take antihistamines
  • therapy with b-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. Contact the study team or a site near you to ask about taking part.

Poland1 site

  • Medical University of Warsaw

    Warsaw, 02-091

Other trials in Poland

About this study

Official title: Induction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy - Evaluation of Efficacy and Safety

This is an experimental, interventional study, following on from a clinical trial comparing the efficacy and safety of oral immunotherapy with low and high doses of sesame protein, in which patient desensitisation was achieved (High and Low Dose Oral Sesame Immunotherapy - Comparison of Efficacy and Safety, NCT05158413).

The aim of this study is to assess a sustained unresponsiveness (SU) to sesame protein after at least 8 months of previously assigned high- or low-dose sesame OIT, followed by 4-week-allergen avoidance, and verified by an open oral food challenge (OOFC).

Read the detailed description

Oral immunotherapy is considered the most effective treatment for food allergy. There are two main goals of food immunotherapy: achievement of desensitisation and sustained unresponsiveness.

Desensitisation involves achieving temporary tolerance of the allergenic food by the patient only during regular intake of the allergen. The most desirable effect of immunotherapy is to achieve sustained unresponsiveness, i.e. to maintain the absence of adverse symptoms to a given allergen after specific immunotherapy has been discontinued for a defined period of time.

The study is a continuation of a clinical trial NCT05158413 which was designed to compare the efficacy and safety of oral immunotherapy (OIT) with low or high doses of sesame protein (300 or 1200 mg, respectively) in children with a confirmed diagnosis of sesame allergy. The participants of current study will be recruited from patients who have accomplished their per-protocol participation in previous trial.

Patients will receive the same maintenance dose of sesame allergen, which was used in previous trial (300 or 1200 mg, respectively), for 32 weeks (+/-2 weeks). Then, OIT will be discontinued for 4 weeks with strict sesame avoidance. Subsequently, an open oral food challenge (OOFC) will be performed to assess the achievement of sustained unresponsiveness.

Conditions
Food Allergy
Being tested
High dose OIT, Low dose OIT
Keywords
sesame, food allergy, sustained unresponsiveness, 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 dose OITDietary supplement

    Patients will receive daily a high dose of the sesame paste (1200 mg sesame protein) mixed with well-tolerated fruit mousse or bread.

  • Low dose OITDietary supplement

    Patients will receive daily a low dose of the sesame paste (300 mg sesame protein) mixed with well-tolerated fruit mousse or bread.

Study groups in NCT05923216
Study groupRoleWhat they receive
High doseExperimental20 patients Intervention: Dietary Supplement: High dose OIT
Receives: Dietary Supplement: High dose OIT
Low doseActive comparator20 patients Intervention: Dietary Supplement: Low dose OIT
Receives: Dietary Supplement: Low dose OIT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sustained unresponsiveness to a sesame protein after discontinuing oral immunotherapy for 4 weeks.

    Percentage of patients tolerating their maintenance dose of sesame protein after a 4-week break in immunotherapy

    Measured: Up to 9 months after starting maintenance phase

  2. The highest tolerated dose of sesame protein after discontinuing oral immunotherapy for 4 weeks.

    Sustained unresponsiveness assessed as the highest tolerated dose of sesame protein at oral food challenge.

    Measured: Up to 9 months after starting maintenance phase

Secondary outcomes (4)

  1. Adverse events

    Number and severity of adverse events during OIT treatment and at OOFC will be assessed and compared between both groups.

    Measured: Up to 9 months after starting maintenance phase

  2. Laboratory data

    Change in sesame serum immunoglobulin E (IgE) level and immunoglobulin G4 (IgG4) level at different time points: before immunotherapy, at the end of the maintenance phase and after a 4-week break in immunotherapy, assessed for each individual and compared between groups.

    Measured: Up to 9 months after starting maintenance phase

  3. Skin prick test (SPT)

    Difference in wheal diameter in skin prick tests (SPT) assessed between groups at the respective time points: before immunotherapy, at the end of the maintenance phase and after a 4-week break in immunotherapy.

    Measured: Up to 9 months after starting maintenance phase

  4. Tolerance of a single dose of 4000 mg of sesame protein

    Percentage of patients tolerating a single dose of 4000 mg of sesame protein after a 4- week break in immunotherapy.

    Measured: Up to 9 months after starting maintenance phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2023
  2. Study start24 Mar 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05923216
Sponsor's protocol ID
Sesame Protocol - SU
Status last verified
Jan 2025
First submitted
19 Jun 2023
Last updated
31 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23195525

  • Pajno 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 29205393

  • 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.

    PubMed 28490893

  • Burks 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 29307409

  • 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.

    PubMed 31150789

  • 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.

    PubMed 22610362

Questions about this trial

What is this clinical trial studying?

A study testing High dose OIT and 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 3 inclusion and 17 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: enrolling by invitation, as of the sponsor's last update on 31 Jan 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained unresponsiveness to a sesame protein after discontinuing oral immunotherapy for 4 weeks. (time frame: Up to 9 months after starting maintenance phase). The study lists 2 primary outcomes in all. 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 NCT05923216, which also lists 6 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 31 Jan 2025.

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