Gut Microbiota is Associated With Autoimmune Thyroid Disease

Study Overview
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Brief Summary
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Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's disease (GD), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in AITD patients and healthy controls.

Detailed Description
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Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's disease (GD), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. These two diseases are clinically diverse because in HT, T cells aid in the destruction of the thyroid epithelial cells (thyrocytes) and thyroid epithelial structure and eventual fibrous replacement of parenchymal tissue leading to hypothyroidism, whereas GD is primarily a humoral disease where auto-antibodies are generated against the thyroid stimulating hormone receptor (TSHR) leading to hyperthyroidism (2,163-165). However, these diseases still share several immunological features，and the disease may progress from one state to another as the autoimmune process evolves. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in AITD patients and healthy controls.

Official Title
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Gut Microbiota is Associated With Autoimmune Thyroid Disease(GD and HT)

Conditions
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Gut Microbiota

Intervention / Treatment
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* Drug: Methimazole Pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 65 years Male or female gender Euthyroidism (normal FT3, FT4, and TSH plasma levels without hormonal therapy) 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, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine Known history of disease with an autoimmune component such as MS, rheumatoid arthritis, IBS, and IBD History of malignancy or any gastrointestinal tract surgery (e.g., gastrectomy, bariatric surgery, colectomy, ileectomy, cholecystectomy or appendectomy).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hashimoto's thyroiditis<br>Hashimoto's thyroiditis (HT) is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. | |
| healthy controls<br>healthy controls are all from normal volunteers | |
| treatment_naive GD<br>GD is primarily a humoral disease where autoantibodies are generated against the thyroid stimulating hormone receptor (TSHR) leading to hyperthyroidism. | |
| treated GD<br>GD patients treated by Methimazole Pill | Drug: Methimazole Pill<br>* Hyperthyroidism patients are treated with Methimazole Pill according to the guidelines<br>* Other names: Methimazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 16S rRNAgene sequencing was used to measure the diversity of gut microbiota | Intestinal microbes are different in different groups | HC, treatment_naive HT and treatment_naive GD patients samples were collected at the enroll. Treated GD patients were collected until thyroid function resumed to the normal for at least 3 months of methimazole withdrawal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thyroid function tested by Chemiluminescence method | Serum results are different in different groups and different time point | Treatment_naive GD and treatment_naive HT patients thyroid function were tested at the enroll and after 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graves' Disease, Methimazole, Levothyroxine sodium, 16S rRNA gene, Metabonomics, Gut Microbiota, Hashimoto Thyroiditis