Clinical trial NCT03447093: The Oral Microbiota is Associated With Autoimmune Thyroiditis
Official title: The Oral Microbiota in Autoimmune Thyroiditis is Distinctive And Predictive
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbiota
Keywords: oral microbiota
16S rRNA gene
Graves' disease
Methimazole
Propylthiouracil
Hashimoto's thyroiditis
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients were included according to the inclusion and exclusion criteria

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.

Eligibility criteria: 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

Primary outcomes:
measure: Transcriptional changes in oral microbiota
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcomes:
measure: Serum thyroid function changed
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
Other outcomes:
measure: Serum thyroid related antibodies changed
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months
Locations:
city: Harbin
country: China
facility: First affiliated hospital of Harbin medical university
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Yunwei Wei
role: STUDY_DIRECTOR
References:
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