Back to resultsInduction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy
Primary Purpose
Food Allergy
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
High dose OIT
Low dose OIT
Sponsored by
About this trial
This is an interventional treatment trial for Food Allergy focused on measuring sesame, food allergy, sustained unresponsiveness, children
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Sites / Locations
- Medical University of Warsaw
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High dose
Low dose
Arm Description
20 patients Intervention: Dietary Supplement: High dose OIT
20 patients Intervention: Dietary Supplement: Low dose OIT
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Adverse events
Number and severity of adverse events during OIT treatment and at OOFC will be assessed and compared between both groups.
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.
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.
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.
Full Information
NCT ID
NCT05923216
First Posted
June 19, 2023
Last Updated
June 19, 2023
Sponsor
Medical University of Warsaw
1. Study Identification
Unique Protocol Identification Number
NCT05923216
Brief Title
Induction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy
Official Title
Induction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy - Evaluation of Efficacy and Safety
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 24, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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, 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
sesame, food allergy, sustained unresponsiveness, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High dose
Arm Type
Experimental
Arm Description
20 patients Intervention: Dietary Supplement: High dose OIT
Arm Title
Low dose
Arm Type
Active Comparator
Arm Description
20 patients Intervention: Dietary Supplement: Low dose OIT
Intervention Type
Dietary Supplement
Intervention Name(s)
High dose OIT
Intervention Description
Patients will receive daily a high dose of the sesame paste (1200 mg sesame protein) mixed with well-tolerated fruit mousse or bread.
Intervention Type
Dietary Supplement
Intervention Name(s)
Low dose OIT
Intervention Description
Patients will receive daily a low dose of the sesame paste (300 mg sesame protein) mixed with well-tolerated fruit mousse or bread.
Primary Outcome Measure Information:
Title
Sustained unresponsiveness to a sesame protein after discontinuing oral immunotherapy for 4 weeks.
Description
Percentage of patients tolerating their maintenance dose of sesame protein after a 4-week break in immunotherapy
Time Frame
Up to 9 months after starting maintenance phase
Title
The highest tolerated dose of sesame protein after discontinuing oral immunotherapy for 4 weeks.
Description
Sustained unresponsiveness assessed as the highest tolerated dose of sesame protein at oral food challenge.
Time Frame
Up to 9 months after starting maintenance phase
Secondary Outcome Measure Information:
Title
Adverse events
Description
Number and severity of adverse events during OIT treatment and at OOFC will be assessed and compared between both groups.
Time Frame
Up to 9 months after starting maintenance phase
Title
Laboratory data
Description
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.
Time Frame
Up to 9 months after starting maintenance phase
Title
Skin prick test (SPT)
Description
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.
Time Frame
Up to 9 months after starting maintenance phase
Title
Tolerance of a single dose of 4000 mg of sesame protein
Description
Percentage of patients tolerating a single dose of 4000 mg of sesame protein after a 4- week break in immunotherapy.
Time Frame
Up to 9 months after starting maintenance phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarzyna Grzela, PhD, MD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Study Chair
Facility Information:
Facility Name
Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-091
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23195525
Citation
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.
Results Reference
background
PubMed Identifier
29205393
Citation
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.
Results Reference
background
PubMed Identifier
28490893
Citation
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.
Results Reference
background
PubMed Identifier
29307409
Citation
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.
Results Reference
background
PubMed Identifier
31150789
Citation
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.
Results Reference
background
PubMed Identifier
22610362
Citation
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.
Results Reference
background
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Induction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy
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