Allergy to Shrimp, Immunotherapy
Conditions
Keywords
Shrimp allergy, Oral immunotherapy, Specific Immunoglobulin E, Skin sensitization
Brief summary
Oral immunotherapy is effective in desensitized food allergy. Shrimp allergy is increasing in Thailand. So the purpose of our study is to determine level of specific immunoglobulin E antibodies to shrimp, Immunoglobulin G4 and immunoblot analysis in shrimp allergy patients after shrimp oral immunotherapy.
Detailed description
All subject in this study were sensitized to shrimp. All patient was clinically evaluated, with focus on shrimp allergy by medical history, medical examination and gold standard oral food challenge test. Compare oral immunotherapy to shrimp and shrimp avoidance. Blood sample was taken for baseline determination of immunoglobulin E antibodies to shrimp. The primary outcome was the specific immunoglobulin E antibodies to shrimp,Immunoglobulin G4 and immunoblot analysis in case that oral immunotherapy.
Interventions
OTHERshrimp allergy with intend to eat shrimp
shrimp allergy with intend to eat shrimp and treat with oral immunotherapy
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age 12 - 40 years old * History of Immunoglobulin E-mediated shrimp allergy \> 3 episode/year or disturb quality of life * Positive oral food challenge test for shrimp
Exclusion criteria
* History of shrimp anaphylaxis (include cardiovascular or neurological symptoms) * Shellfish dependent exercise induced anaphylaxis * History of cardiovascular disease, uncontrolled asthma, severe atopic dermatitis * History of Beta-blocker, Angiotensin-converting enzyme inhibitor, Angiotensin receptor blocker, Calcium channel blocker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Eliciting Dose of Shrimp During Oral Food Challenge | Baseline and 12 months | Change in the eliciting dose (ED) of shrimp protein during oral food challenge from baseline to 12 months in participants with shrimp allergy undergoing shrimp oral immunotherapy compared with avoidance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event From Shrimp Oral Immunotherapy | 1 year | To follow up adverse event from Shrimp oral immunotherapy |
Countries
Thailand
Contacts
PRINCIPAL_INVESTIGATORPunchama Pacharn, MD
Mahidol University
Participant flow
Recruitment details
aged 12 to 40 years who met three of these criteria: Documented history of immediate allergic reactions within 4 hours of consuming any type of shrimp, with a positive SPT (mean wheal diameter at least 3mm larger than the negative control) or a shrimp-sIgE level ≥ 0.35 KUA/L and positive OFC test for L.Vannamei (2) Willing to consume L. Vannamei despite allergy.
Pre-assignment details
All participants underwent screening OFC before entering to study. Participants were randomly assigned in a 1:1 ratio to either the shrimp OIT group or the avoidance group using block randomization
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 16.2 year |
| immunological status | 24.25 kUA/L |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Thailand | 10 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 1 / 10 | 4 / 10 |
Outcome results
None listed