Comparison Efficacy Between Two Different Frequency of Maintenance Dose Oral Immunotherapy

Comparison Efficacy Between Two Different Frequency of Maintenance Dose-oral Immunotherapy for Children With Wheat Allergy

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

Study Overview

• Status: Recruiting
• Conditions: Immunotherapy; Wheat Hypersensitivity
• Intervention / Treatment: Other: Wheat (Four times per week)

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

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Punchama Pacharn, MD; Phone Number: 5670 024197000; Email: punchama@gmail.com

Study Locations

• Thailand
  • Bangkok
    • Bangkoknoi, Bangkok, Thailand, 10700
      • Recruiting
      • Siriraj Hospital
      • Contact: Punchama Pacharn, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Four per week; Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT	Other: Wheat (Four times per week); Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT
No Intervention: Once daily; Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific IgE to wheat	Specific IgE to wheat	13 months
Specific IgG4 to wheat	Specific IgG4 to wheat	13 months
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

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Punchama Pacharn, MD, Mahidol University, Siriraj Hospital,Thailand

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): March 22, 2027
• Study Completion (Estimated): March 22, 2027

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Immunotherapy; Wheat Hypersensitivity; Short term unresponsiveness
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Wheat Hypersensitivity
• Other Study ID Numbers: 069/2566(IRB3)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No