Intestinal Microbiota and Treatment of GD

• Conditions: Microbiota
• Interventions: Drug: Methimazole Pill; Drug: Propylthiouracil Pill

• Registration Number: NCT03433352
• Lead Sponsor: 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.

Study Timeline

• Status Verified: 2017-12
• Study Start: 2017-12-23
• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-13
• Last Update Submitted: 2018-02-13
• Study First Posted: 2018-02-14
• Last Update Posted: 2018-02-14
• Primary Completion: 2018-12-23
• Study Completion: 2019-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Recrudescence group	Methimazole Pill	30 GD patients who received recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill
Recrudescence group	Propylthiouracil Pill	30 GD patients who received recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill
No recrudescence group	Propylthiouracil Pill	30 GD patients who did not receive recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill
No recrudescence group	Methimazole Pill	30 GD patients who did not receive recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill

Primary Outcome Measures

Name	Time	Method
Transcriptional changes in gut microbiota	Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal	The microbiota measured by 16S rRNA gene

Secondary Outcome Measures

Name	Time	Method
Serum thyroid function changed	Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal	Serum thyroid function measured by Immunohistochemistry

Trial Locations

Locations (1)

First affiliated hospital of Harbin medical university; 🇨🇳 Harbin, Heilongjiang, China