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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shrimp allergy with Intend to eat shrimp | Experimental | Case shrimp Immunoglobulin E mediated allergy and intend to eat shrimp and start oral immunotherapy for shrimp |
|
| Shrimp allergy with avoid shrimp | No Intervention | Case shrimp allergy with avoid shrimp |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| shrimp allergy with intend to eat shrimp | Other | shrimp allergy with intend to eat shrimp and treat with oral immunotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Eliciting Dose of Shrimp During Oral Food Challenge | 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. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event From Shrimp Oral Immunotherapy | To follow up adverse event from Shrimp oral immunotherapy | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Punchama Pacharn, MD | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Bangkoknoi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29205393 | Background | Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5. |
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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
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | shrimp OIT for daily oral dosing or to follow an avoidance regimen. The OIT protocol consisted of four phases: (1) Baseline OFC, 2) The dose was increased every 4 weeks until reaching 20 grams of shrimp (approximately three white Pacific shrimps, 71-90 count per pound), providing roughly 7 grams of shrimp protein per shrimp daily. We selected a daily maintenance dose of three shrimps, as the optimal maintenance dose for shrimp OIT has not yet been established. (3) Daily maintenance, and (4) Discontinuation with desensitization assessment. During the build-up phase, doses were increased by 20-50% |
| FG001 | Avoidance Group | avoid shellfish along study period |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Shrimp Allergy With Avoid Shrimp | Case shrimp allergy with avoid shrimp |
| BG001 | Shrimp Allergy With Intend to Eat Shrimp | Case shrimp Immunoglobulin E mediated allergy and intend to eat shrimp and start oral immunotherapy for shrimp |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Eliciting Dose of Shrimp During Oral Food Challenge | 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. | Participants who completed the 12-month oral food challenge were included in the analysis. | Posted | Median | Inter-Quartile Range | mg | Baseline and 12 months |
|
from enrollment until end of 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Shrimp Allergy With Intend to Eat Shrimp | Case shrimp Immunoglobulin E mediated allergy and intend to eat shrimp and start oral immunotherapy for shrimp |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anaphylaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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Limitations include the small sample size, short duration 12 month
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Punchama Pacharn | Mahidol university | 02-4195670 | punchama@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2020 | Mar 14, 2026 | Prot_SAP_000.pdf |
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| BG002 | Total | Total of all reporting groups |
| Inter-Quartile Range |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| immunological status | specific IgE shrimp | Median | Inter-Quartile Range | kUA/L |
|
Case shrimp allergy with avoid shrimp
|
|
| Secondary | Adverse Event From Shrimp Oral Immunotherapy | To follow up adverse event from Shrimp oral immunotherapy | Not Posted | 1 year | Participants |
| 0 |
| 10 |
| 1 |
| 10 |
| 0 |
| 10 |
| EG001 | Shrimp Allergy With Avoid Shrimp | Case shrimp allergy with avoid shrimp | 0 | 10 | 4 | 10 | 0 | 10 |
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