Intestinal Microbiota and Treatment of GD

Study Overview
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Brief Summary
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Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. 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 GD patients and healthy controls and analyse the relationship between intestinal microbiota and GD drug therapy.

Detailed Description
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Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. 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 GD patients and healthy controls before and found that gut microbiota changed between GD patients and healthy controls.But there are few articles on the relationship between intestinal microbiota and drug treatment of GD, so Investigators explored the relationship between intestinal microflora and methimazole treatment for GD.

Official Title
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The Effect of Intestinal Microbiota on Treatment Sensitivity and Prognosis of Methimazole for GD

Conditions
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Microbiota

Intervention / Treatment
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* Drug: Methimazole Pill
* Drug: Propylthiouracil Pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 to 65 years GD was clinical diagnosed and accept the standard treatment of methimazole or propylthiouracil and thyroid function returned to 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

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 |
| --- | --- |
| Control group<br>30 healthy volunteers were included in the healthy control group | |
| Recrudescence group<br>30 GD patients who received recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill | Drug: Methimazole Pill<br>* Patients who developed GD received methimazole treatment<br>Drug: Propylthiouracil Pill<br>* Patients who developed GD received propylthiouracil treatment<br>|
| No recrudescence group<br>30 GD patients who did not receive recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill | Drug: Methimazole Pill<br>* Patients who developed GD received methimazole treatment<br>Drug: Propylthiouracil Pill<br>* Patients who developed GD received propylthiouracil treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcriptional changes in gut microbiota | The microbiota measured by 16S rRNA gene | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum thyroid function changed | Serum thyroid function measured by Immunohistochemistry | Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut microbiota, 16S rRNA gene, Graves' disease, Methimazole, Propylthiouracil