Induction of Sustained Unresponsiveness to Sesame Using High- and Low-dose Sesame Oral Immunotherapy - Evaluation of Efficacy and Safety
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Sustained unresponsiveness to a sesame protein after discontinuing oral immunotherapy for 4 weeks.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients who have accomplished their per-protocol participation in trial NCT
- •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
Arms & Interventions
High dose
20 patients Intervention: Dietary Supplement: High dose OIT
Intervention: High dose OIT (Dietary Supplement)
Low dose
20 patients Intervention: Dietary Supplement: Low dose OIT
Intervention: Low dose OIT (Dietary Supplement)
Outcomes
Primary Outcomes
Sustained unresponsiveness to a sesame protein after discontinuing oral immunotherapy for 4 weeks.
Time Frame: Up to 9 months after starting maintenance phase
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.
Time Frame: Up to 9 months after starting maintenance phase
Sustained unresponsiveness assessed as the highest tolerated dose of sesame protein at oral food challenge.
Secondary Outcomes
- Skin prick test (SPT)(Up to 9 months after starting maintenance phase)
- Adverse events(Up to 9 months after starting maintenance phase)
- Laboratory data(Up to 9 months after starting maintenance phase)
- Tolerance of a single dose of 4000 mg of sesame protein(Up to 9 months after starting maintenance phase)