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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	4 Years - 17 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05923216
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Medical University of Warsaw
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Katarzyna Grzela, PhD, MD
Principal Investigator Affiliation	Medical University of Warsaw
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	Poland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy

Additional Details

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.

Arms & Interventions

Arms

Experimental: High dose

20 patients Intervention: Dietary Supplement: High dose OIT

Active Comparator: Low dose

20 patients Intervention: Dietary Supplement: Low dose OIT

Interventions

Dietary Supplement: - High dose OIT

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

Dietary Supplement: - Low dose OIT

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

Contact a Trial Team

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International Sites

Medical University of Warsaw, Warsaw, Poland

Status

Address

Medical University of Warsaw

Warsaw, , 02-091

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