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HLA-DRB1 and HLA-DQB1 Genotyping for Autoantibody-positive and -Negative Patients With Atrophic Glossitis or Burning Mouth Syndrome

Primary Purpose

Atrophic Glossitis, Burning Mouth Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Supplementation of vitamin B complex, C, B12, folic acid, Iron and Zinic
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Atrophic Glossitis, Burning Mouth Syndrome focused on measuring atrophic glossitis, burning mouth syndrome, gastric parietal cell antibody, thyroglobulin antibody, thyroid microsomal antibody, HLA-DR, HLA-DQ

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of atrophic glossitis or burning mouth syndrome.
  • Patient's age is between 20 and 80 years.

Exclusion Criteria:

  • An expectant mother or patients without atrophic glossitis or burning mouth syndrome.
  • Patients have atrophic glossitis or burning mouth syndrome but refuse to take blood sample.
  • Betel guid chewers or heavy alcohol drinkers, patients with autoimmune disease, stroke, liver or kidney dysfunction, or cardiovascular disaeses.

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HLA-DR and DQ antigens

Arm Description

Isolation of patient's lymphocytes from 10 cc of blood to determine the HLA-DR and DQ antigens at the first visit.

Outcomes

Primary Outcome Measures

Number of participants with finding the HLA-DRB1 and HLA-DQB1

Secondary Outcome Measures

Number of participants with finding the HLA-DRB1-DQB1 haplotype

Full Information

First Posted
June 10, 2013
Last Updated
January 28, 2016
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01931293
Brief Title
HLA-DRB1 and HLA-DQB1 Genotyping for Autoantibody-positive and -Negative Patients With Atrophic Glossitis or Burning Mouth Syndrome
Official Title
HLA-DRB1 and HLA-DQB1 Genotyping for Autoantibody-positive and -Negative Patients With Atrophic Glossitis or Burning Mouth Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with atrophic glossitis (AG) or burning mouth syndrome (BMS) are frequently encountered in the oral mucosal disease clinic. Our previous studies found a significantly higher frequency (26.7%) of serum gastric parietal cell antibody (GPCA) and a significantly higher frequency (31%) of serum thyroglobulin antibody (TGA) or thyroid microsomal antibody (TMA) in AG patients than in healthy control subjects. Moreover, there is also a significantly higher frequency (13.3%) of serum GPCA or a significantly higher frequency (23.5%) of serum TGA or TMA in BMS patients than in healthy control subjects. Because patients with one organ-specific autoantibody are prone to have another organ-specific autoantibody in sera, we also evaluated whether AG or BMS patients with GPCA are prone to have TGA or TMA in sera and vice versa. We further found that 25.3% of TGA- or TMA-positive AG or BMS patients also have GPCA, 32.3% GPCA-positive AG or BMS patients also have TGA, and 30.6% GPCA-positive AG or BMS patients also have TMA in their sera. Without proper diagnosis and treatment, patients with GPCA are more likely to develop autoimmune atrophic gastritis and subsequently progress to gastric carcinoma, and patients with TGA or TMA may develop autoimmune thyroid disease and finally result in thyroid dysfunction. In addition, previous studies have shown a close association of the HLA-DR or HLA-DQ loci with the presence of autoantibodies (such as GPCA, TGA or TMA) in patients with different types of autoimmune disease. Therefore, in the following 3-year research project, we plan to collect 300 AG and 450 BMS patients from the oral mucosal disease clinic of Department of Dentistry, National Taiwan University Hospital. For each year, 100 AG and 150 BMS patients are collected. A 10-cc blood sample will be drawn from each patient, with 5 cc being used for the determination of the serum levels of GPCA, TGA and TMA and another 5 cc being used for the HLA-DRB1 and HLA-DQB1-genotyping using the polymerase chain reaction with sequence-specific primer (PCR-SSP) typing technique. At the end of this 3-year study, we will realize the frequencies of presence of GPCA, TGA and TMA in sera of our 300 AG or 450 BMS patients. After statistical analyses, we will also know which specific HLA-DRB1 or HLA-DQB1 allele and which specific DRB1-DQB1 haplotype are responsible for the possession of GPCA, TGA or TMA in sera of our AG or BMS patients. In addition, we will understand which specific HLA-DRB1 or HLA-DQB1 allele and which specific DRB1-DQB1 haplotype are responsible for the possession of GPCA in TGA- or TMA-positive AG or BMS patients as well as for the possession of TGA or TMA in GPCA-positive AG or BMS patients. With this important information in mind, we can predict the development of the specific autoimmune diseases such as autoimmune atrophic gastritis and autoimmune thyroid diseases and then adopt proper early diagnosis and treatment to prevent the future occurrence of these diseases and their potential complications (such as gastric carcinoma or thyroid dysfunction).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Glossitis, Burning Mouth Syndrome
Keywords
atrophic glossitis, burning mouth syndrome, gastric parietal cell antibody, thyroglobulin antibody, thyroid microsomal antibody, HLA-DR, HLA-DQ

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HLA-DR and DQ antigens
Arm Type
Experimental
Arm Description
Isolation of patient's lymphocytes from 10 cc of blood to determine the HLA-DR and DQ antigens at the first visit.
Intervention Type
Dietary Supplement
Intervention Name(s)
Supplementation of vitamin B complex, C, B12, folic acid, Iron and Zinic
Intervention Description
Vitamin Supplement therapy
Primary Outcome Measure Information:
Title
Number of participants with finding the HLA-DRB1 and HLA-DQB1
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of participants with finding the HLA-DRB1-DQB1 haplotype
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Number of participants with finding the presence of serum GPCA, TGA and TMA
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of atrophic glossitis or burning mouth syndrome. Patient's age is between 20 and 80 years. Exclusion Criteria: An expectant mother or patients without atrophic glossitis or burning mouth syndrome. Patients have atrophic glossitis or burning mouth syndrome but refuse to take blood sample. Betel guid chewers or heavy alcohol drinkers, patients with autoimmune disease, stroke, liver or kidney dysfunction, or cardiovascular disaeses.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andy Sun
Phone
+8862-23123456
Ext
67723
Email
andysun7702@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andy Sun, Professor
Organizational Affiliation
No Organizatioinal Affiliation
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Test2
ZIP/Postal Code
test3
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andy Sun, Professor
Phone
+886-2-23123456
Ext
67702
Email
andysun7702@yahoo.com.tw

12. IPD Sharing Statement

Learn more about this trial

HLA-DRB1 and HLA-DQB1 Genotyping for Autoantibody-positive and -Negative Patients With Atrophic Glossitis or Burning Mouth Syndrome

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