The Oral Microbiota is Associated With Autoimmune Thyroiditis

• Conditions: Microbiota
• Interventions: Drug: Methimazole Pill; Drug: Propylthiouracil Pill

• Registration Number: NCT03447093
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief Summary

Autoimmune thyroiditis (AITD) mainly includes Hashimoto's thyroiditis (HT) and Grave's disease (GD). Studies have shown that autoimmune thyroiditis is closely related to microbial disorders such as autoimmune thyroiditis However, there is no report on the relationship between oral microecology and autoimmune thyroiditis. Therefore, our group will study the correlation between oral microbiota and AITD.

Detailed Description

Autoimmune thyroiditis (AITD) mainly includes Hashimoto's thyroiditis (HT) and Grave's disease (GD). Studies have shown that autoimmune thyroiditis is closely related to microbiological disorders. Intestinal microelements Both ecology and oral microecology belong to the category of microorganisms. It has been reported in the literature that intestinal microecology occurs disorder of autoimmune thyroiditis. However, there is no report on the correlation between oral microecology and autoimmune thyroiditis. When oral microbe flora When the immune system is disrupted, the immune balance is broken, the immune system is over-active, and the autoimmune disease (AID) is lost to the autoantigens and non-pathogenic commensal microbial flora antigens, including rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, inflammatory bowel disease, and allergic diseases. However, the association between oral microbial flora and AITD remains unclear. . Therefore, the research group will carry out the correlation between oral microbial flora and AITD.

Study Timeline

• Status Verified: 2017-12
• Study Start: 2017-12-23
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-25
• Last Update Submitted: 2018-02-25
• Study First Posted: 2018-02-27
• Last Update Posted: 2018-02-27
• Primary Completion: 2019-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Aged 18 to 65 years
• GD was clinical diagnosed and thyroid function returned to normal
• HT was clinical diagnosed and thyroid function is normal.

Exclusion Criteria

• Pregnancy
• Lactation
• Cigarette smoking
• Alcohol addiction
• Hypertension
• Diabetes mellitus
• Lipid dysregulation
• BMI > 27
• Recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
• History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
• History of malignancy or any gastrointestinal tract surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Drug treatment group	Methimazole Pill	30 GD patients who received treatment with Methimazole Pill or propylthiouracil pill
Drug treatment group	Propylthiouracil Pill	30 GD patients who received treatment with Methimazole Pill or propylthiouracil pill

Primary Outcome Measures

Name	Time	Method
Transcriptional changes in oral microbiota	Baseline, 3 months, 6 months, 9 months, 12 months	The microbiota measured by 16S rRNA gene

Secondary Outcome Measures

Name	Time	Method
Serum thyroid function changed	Baseline, 3 months, 6 months, 9 months, 12 months	Serum thyroid function measured by Immunohistochemistry

Trial Locations

Locations (1)

First affiliated hospital of Harbin medical university; 🇨🇳 Harbin, Heilongjiang, China