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Oral immunotherapy(OIT) is effective in desensitized food allergy. OIT protocols are not standardized, and a wide heterogeneity exists in the literature . So the purpose of our study is to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT
All subject in this study were patients with history of IgE mediated wheat allergy and positive OFC test. All of them received wheat OIT and reached target maintenance dose of wheat OIT.
The primary outcome was to compare short term unresponsiveness rate between once daily dose and four times/week dose during one year maintenance phase of wheat OIT. Other outcomes were collected during the projected such as blood and skin examination for immunologic parameter, changing in Body weight, WA, WH and BMI, compliance, adverse reactions, rates of medication used during OIT and quality of life
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Four per week | Experimental | Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT |
|
| Once daily | No Intervention | Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wheat (Four times per week) | Other | Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short term unresponsiveness rate | Short term unresponsiveness rate between once daily dose and four times/week dose .during maintenance phase of wheat OIT. Short term unresponsiveness means patients who pass the oral food challenge test after stopping oral immunotherapy for a short period | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Specific IgE to wheat | Specific IgE to wheat | 13 months |
| Specific IgG4 to wheat | Specific IgG4 to wheat | 13 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Punchama Pacharn, MD | Contact | 024197000 | 5670 | punchama@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Punchama Pacharn, MD | Mahidol University, Siriraj Hospital,Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Recruiting | 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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| ID | Term |
|---|---|
| D021182 | Wheat Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D005433 | Flour |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Changing in Body weight | Changing in Body weight in kilograms | 13 months |
| Compliance | Compliance of wheat ingestion (group A: every day, groupB: 4 days/weeks). Compliance can be calculated by dividing the number of days on which wheat is actually ingested by the total number of days prescribed for wheat consumption. | 12 months |
| Adverse reactions | Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system | 13 months |
| Quality of life by using FAQLQ-PF | Quality of life before and after enrollment by using FAQLQ-PF | 13 months |