NCT06035328

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jul 2023Mar 2027

First Submitted

Initial submission to the registry

April 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2027

Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

3.7 years

First QC Date

April 18, 2023

Last Update Submit

May 6, 2025

Conditions

Wheat HypersensitivityImmunotherapy

Keywords

Wheat HypersensitivityImmunotherapyShort term unresponsiveness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Specific IgE to wheat

    13 months

  • Specific IgG4 to wheat

    13 months

  • Changing in Body weight

    13 months

  • Compliance

    12 months

  • Adverse reactions

    13 months

  • +1 more secondary outcomes

Study Arms (2)

Four per week

EXPERIMENTAL

Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT

Other: Wheat (Four times per week)

Once daily

NO INTERVENTION

Case wheat allergy that on once daily dose during one year maintenance phase of wheat OIT

Interventions

Wheat (Four times per week)OTHER

Case wheat allergy that on four times/week dose during one year maintenance phase of wheat OIT

Four per week

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Related 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.

    PMID: 29205393BACKGROUND

MeSH Terms

Conditions

Wheat Hypersensitivity

Interventions

Flour

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Punchama Pacharn, MD

    Mahidol University, Siriraj Hospital,Thailand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Punchama Pacharn, MD

CONTACT

024197000punchama@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

September 13, 2023

Study Start

July 1, 2023

Primary Completion (Estimated)

March 22, 2027

Study Completion (Estimated)

March 22, 2027

Last Updated

May 9, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)