NCT03487315

Brief Summary

  • To study Major allergen in Wheat anaphylaxis in Thai population
  • To study and compare demographic data between group of wheat anaphylaxis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
Last Updated

April 4, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

August 31, 2017

Last Update Submit

March 27, 2018

Conditions

Wheat AllergyAnaphylaxis FoodAnaphylaxis Exercise

Outcome Measures

Primary Outcomes (1)

  • Major allergen sensitized by Thai Patients with Wheat anaphylaxis

    To Identify major allergen (most component of protein that cause wheat allergy) between wheat anaphylaxis (low Specific IgE and high Specific IgE) and wheat dependent, exercise induced anaphylaxis by using immunoblot method (Electrophoresis). The results will be shown in electrophoresis gel and can identify in molecular weight (KDa) of protein which represent to major allergen of wheat protein.

    1 hour

Study Arms (1)

specific IgE

EXPERIMENTAL

Different level of specific IgE and immunoblot

Diagnostic Test: immunoblot

Interventions

immunoblotDIAGNOSTIC_TEST

immunoblot

specific IgE

Eligibility Criteria

Age1 Year - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Wheat anaphylaxis patient aged 1-60 years, who received treatment at division of allergy, department of Pediatrics and Medicine, Siriraj Hospital from 2001 to 2016

You may not qualify if:

  • Loss follow up
  • No consent form
  • Celiac disease, Autoimmune disease was diagnosed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (1)

  • Nilsson N, Sjolander S, Baar A, Berthold M, Pahr S, Vrtala S, Valenta R, Morita E, Hedlin G, Borres MP, Nilsson C. Wheat allergy in children evaluated with challenge and IgE antibodies to wheat components. Pediatr Allergy Immunol. 2015 Mar;26(2):119-25. doi: 10.1111/pai.12334.

    PMID: 25601168RESULT

MeSH Terms

Conditions

Wheat HypersensitivityExercise-Induced Allergies

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Punchama Pacharn, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

April 4, 2018

Study Start

April 5, 2017

Primary Completion

March 5, 2018

Study Completion

March 5, 2018

Last Updated

April 4, 2018

Record last verified: 2018-03

Locations

TH(1)