Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Allergen-specific Immunotherapy

Study Purpose

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).

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	3 Years - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion criteria:

- 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.

Exclusion criteria:

- 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, - 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 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.	NCT07107451
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.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Poland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy in Children

Additional Details

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.

Arms & Interventions

Arms

Experimental: Maintenance dose of sesame protein (300mg) for 8 months

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.

Experimental: Immunotherapy initiated after one year of sesame avoidance

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.

Interventions

Dietary Supplement: - OIT with low dose sesame protein

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.

Contact a Trial Team

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International Sites

Medical University of Warsaw, Warsaw, Mazowieckie, Poland

Status

Address

Medical University of Warsaw

Warsaw, Mazowieckie, 02-091

Site Contact

Katarzyna Grzela, MD, PhD

[email protected]

+48 22 3179431

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