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

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).

Study Overview

• Status: Unknown
• Conditions: Atrophic Glossitis, Burning Mouth Syndrome
• Intervention / Treatment: Dietary supplement: Supplementation of vitamin B complex, C, B12, folic acid, Iron and Zinic

• Study Type: Interventional
• Enrollment (Anticipated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andy Sun; Phone Number: 67723 +8862-23123456; Email: andysun7702@yahoo.com.tw

Study Locations

• Taiwan
  • Test2
    • Taipei, Test2, Taiwan, test3
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Andy Sun, Professor; Phone Number: 67702 +886-2-23123456; Email: andysun7702@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLA-DR and DQ antigens; Isolation of patient's lymphocytes from 10 cc of blood to determine the HLA-DR and DQ antigens at the first visit.	Dietary supplement: Supplementation of vitamin B complex, C, B12, folic acid, Iron and Zinic; Vitamin Supplement therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with finding the HLA-DRB1 and HLA-DQB1	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with finding the HLA-DRB1-DQB1 haplotype	3 years

Other Outcome Measures

Outcome Measure	Time Frame
Number of participants with finding the presence of serum GPCA, TGA and TMA	3 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Andy Sun, Professor, No Organizatioinal Affiliation

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: June 10, 2013
• First Submitted That Met QC Criteria: August 26, 2013
• First Posted (Estimate): August 29, 2013

Study Record Updates

• Last Update Posted (Estimate): February 1, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: atrophic glossitis, burning mouth syndrome, gastric parietal cell antibody, thyroglobulin antibody, thyroid microsomal antibody, HLA-DR, HLA-DQ
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Stomatognathic Diseases; Mouth Diseases; Pathological Conditions, Anatomical; Tongue Diseases; Syndrome; Burns; Atrophy; Burning Mouth Syndrome; Glossitis; Physiological Effects of Drugs; Micronutrients; Vitamins; Hematinics; Folic Acid; Vitamin B Complex
• Other Study ID Numbers: 201212066RIND