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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06035328
Other study ID # 069/2566(IRB3)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date March 22, 2027

Study information

Verified date September 2023
Source Mahidol University
Contact Punchama Pacharn, MD
Phone 024197000
Email punchama@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date March 22, 2027
Est. primary completion date March 22, 2027
Accepts healthy volunteers No
Gender All
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria: - Age 5-18 years old - Children aged 5-18 years with history of IgE mediated wheat allergy and positive OFC test - Reach target maintenance dose of wheat OIT and ongoing to maintenance phase of wheat OIT Exclusion Criteria: - Patient with low dose OIT protocol - Patients with uncontrolled atopic dermatitis, uncontrolled asthma, or any chronic disease; - Patients who had been treated with some other immunotherapy (eg, SLIT, another OIT) or biologic therapy (eg, Omalizumab) - Patients with a developmental problem or mental disorder - Active eosinophilic gastrointestinal disease in the past 2 years - Use of b-blockers (oral), angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium-channel blockers - Pregnancy or lactation - Patient who could not visit clinic as protocol

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Wheat (Four times per week)
Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT

Locations

Country Name City State
Thailand Siriraj Hospital Bangkoknoi Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Specific IgE to wheat Specific IgE to wheat 13 months
Secondary Specific IgG4 to wheat Specific IgG4 to wheat 13 months
Secondary Changing in Body weight Changing in Body weight in kilograms 13 months
Secondary 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
Secondary Adverse reactions Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system 13 months
Secondary Quality of life by using FAQLQ-PF Quality of life before and after enrollment by using FAQLQ-PF 13 months
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