Intestinal Microbiota and Treatment of GD

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

Sponsors

Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Source First Affiliated Hospital of Harbin Medical University
Brief Summary

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

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.

Overall Status Unknown status
Start Date 2017-12-23
Completion Date 2019-12-20
Primary Completion Date 2018-12-23
Study Type Observational
Primary Outcome
Measure Time Frame
Transcriptional changes in gut microbiota Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal
Secondary Outcome
Measure Time Frame
Serum thyroid function changed Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal
Enrollment 90
Condition
Intervention

Intervention Type: Drug

Intervention Name: Methimazole Pill

Description: Patients who developed GD received methimazole treatment

Intervention Type: Drug

Intervention Name: Propylthiouracil Pill

Description: Patients who developed GD received propylthiouracil treatment

Eligibility

Sampling Method:

Probability Sample

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Yunwei Wei Study Director First Affiliated Hospital of Harbin Medical University
Overall Contact

Last Name: Yunwei Wei

Phone: +86-0451-85553099

Email: [email protected]

Location
Facility: Status: Contact: First affiliated hospital of Harbin medical university Yunwei Wei +86-0451-85553099 [email protected]
Location Countries

China

Verification Date

2017-12-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Arm Group

Label: Control group

Description: 30 healthy volunteers were included in the healthy control group

Label: Recrudescence group

Description: 30 GD patients who received recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill

Label: No recrudescence group

Description: 30 GD patients who did not receive recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill

Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Cross-Sectional

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