The Oral Microbiota is Associated With Autoimmune Thyroiditis

Sponsor

First Affiliated Hospital of Harbin Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03447093

Collaborator

(none)

120

Enrollment

Location

47.3

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microbiota	Drug: Methimazole Pill Drug: Propylthiouracil Pill

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 Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

The Oral Microbiota in Autoimmune Thyroiditis is Distinctive And Predictive

Actual Study Start Date :

Dec 23, 2017

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Control group 30 healthy volunteers were included in the healthy control group
Drug treatment group 30 GD patients who received treatment with Methimazole Pill or propylthiouracil pill	Drug: Methimazole Pill Patients who developed GD received methimazole treatment Drug: Propylthiouracil Pill Patients who developed GD received propylthiouracil treatment
Incipient group 30 untreated GD patients
Hashimoto's thyroiditis group 30 HT patients

Outcome Measures

Primary Outcome Measures

Transcriptional changes in oral microbiota [Baseline, 3 months, 6 months, 9 months, 12 months]
The microbiota measured by 16S rRNA gene

Secondary Outcome Measures

Serum thyroid function changed [Baseline, 3 months, 6 months, 9 months, 12 months]
Serum thyroid function measured by Immunohistochemistry

Other Outcome Measures

Serum thyroid related antibodies changed [Baseline, 3 months, 6 months, 9 months, 12 months]
Serum thyroid related antibodies measured by Immunohistochemistry

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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