Safety and efficacy of oral immunotherapy with lyophilized shrimp extract in patients with shrimp allergy. oral immunotherapy, lyophilized shrimp extract, shrimp allergy
Conditions
Interventions
Oral immunotherapy (OIT) with lyophilized shrimp extract (LSE) for 100 weeks.,Oral immunotherapy (OIT) with lyophilized shrimp extract (LSE) for 152 weeks.
Experimental Other,Experimental Other
Group 1,Group 2
Sponsors
Phramongkutklao College of Medicine, Royal Thai Army Medical Department.
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: Volunteers must be between 20 and 65 years old. 2. Consent: Volunteers must willingly participate in the research and be able to sign the informed consent form. 3. Diagnosis of Shrimp Allergy: Volunteers must have a diagnosed shrimp allergy, evidenced by: - A positive skin prick test to shrimp, and/or - Detected positive serum-specific immunoglobulin E (sIgE) to shrimp, in conjunction with - A positive oral food challenge test (OFC) to shrimp.
Exclusion criteria
Exclusion criteria: 1. Severe or Uncontrolled Asthma: Volunteers with a history of severe or uncontrolled asthma within 3 months prior to project enrollment. 2. Severe Asthma refers to asthma requiring high-dose inhaled corticosteroids (ICS) combined with long-acting beta-2 agonists (LABA) for disease control. 3. Uncontrolled Heart Disease or Hypertension: Volunteers with pre-existing heart disease or uncontrolled hypertension. 4. Abnormal Lung Structure or Function: Volunteers with abnormal lung structure or other abnormal lung function, such as chronic obstructive pulmonary disease (COPD) or pulmonary tuberculosis. 5. Chronic Kidney Failure: Volunteers with chronic kidney failure. 6. Active Cancer Undergoing Chemotherapy: Volunteers with cancer currently undergoing chemotherapy. 7. Primary or Secondary Immunodeficiency: Volunteers with primary or secondary immunodeficiency disorders. 8. Immunosuppressant Medication Use: Volunteers who have received immunosuppressant medication within 3 months prior to project enrollment, except for topical steroids used to relieve symptoms of allergic rhinitis and asthma. 9. Pregnancy, Breastfeeding, or Unwillingness to Use Contraception: Volunteers who are pregnant, planning to become pregnant, breastfeeding, or unwilling to use contraception during the research project. Acceptable contraception methods include abstinence, oral contraceptives, contraceptive injections, or contraceptive implants. 10. Suspected Neuropsychiatric and Mood Disorders: Volunteers with suspected neuropsychiatric and mood disorders. 11. Other Conditions Deemed Limiting by Researcher: Volunteers with any other disease or condition that the researcher deems might limit the conduct of the research or affect the interpretation of results. This includes, but is not limited to, patients with severe shrimp allergy, or patients with uncontrolled allergic conditions such as rhinitis, urticaria, atopic dermatitis, and asthma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions during OIT End of OIT Rate and Severity of adverse reaction | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of OIT End of OIT Induction of clinical desensitization, immunological changes, and tolerability over time | — |
Countries
Thailand
Contacts
Public ContactPanitan Pradubpongsa
Phramongkutklao Hospital
Outcome results
None listed