Back to resultsComparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy
Primary Purpose
Wheat Hypersensitivity, Immunotherapy
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Wheat (Four times per week)
Sponsored by
About this trial
This is an interventional treatment trial for Wheat Hypersensitivity focused on measuring Wheat Hypersensitivity, Immunotherapy, Short term unresponsiveness
Eligibility Criteria
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
Sites / Locations
- Siriraj HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Four per week
Once daily
Arm Description
Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT
Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Specific IgE to wheat
Specific IgE to wheat
Specific IgG4 to wheat
Specific IgG4 to wheat
Changing in Body weight
Changing in Body weight in kilograms
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.
Adverse reactions
Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system
Quality of life by using FAQLQ-PF
Quality of life before and after enrollment by using FAQLQ-PF
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06035328
Brief Title
Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy
Official Title
Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
March 22, 2027 (Anticipated)
Study Completion Date
March 22, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheat Hypersensitivity, Immunotherapy
Keywords
Wheat Hypersensitivity, Immunotherapy, Short term unresponsiveness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Four per week
Arm Type
Experimental
Arm Description
Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT
Arm Title
Once daily
Arm Type
No Intervention
Arm Description
Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT
Intervention Type
Other
Intervention Name(s)
Wheat (Four times per week)
Intervention Description
Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT
Primary Outcome Measure Information:
Title
Short term unresponsiveness rate
Description
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
Time Frame
13 months
Secondary Outcome Measure Information:
Title
Specific IgE to wheat
Description
Specific IgE to wheat
Time Frame
13 months
Title
Specific IgG4 to wheat
Description
Specific IgG4 to wheat
Time Frame
13 months
Title
Changing in Body weight
Description
Changing in Body weight in kilograms
Time Frame
13 months
Title
Compliance
Description
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.
Time Frame
12 months
Title
Adverse reactions
Description
Adverse reaction during treatment will be recorded by using WAO systemic allergic reaction grading system
Time Frame
13 months
Title
Quality of life by using FAQLQ-PF
Description
Quality of life before and after enrollment by using FAQLQ-PF
Time Frame
13 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Punchama Pacharn, MD
Phone
024197000
Ext
5670
Email
punchama@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Punchama Pacharn, MD
Organizational Affiliation
Mahidol University, Siriraj Hospital,Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Punchama Pacharn, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29205393
Citation
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.
Results Reference
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Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy
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