Intestinal Microbiota and Treatment of GD

Sponsor

First Affiliated Hospital of Harbin Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03433352

Collaborator

(none)

Enrollment

Location

23.9

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microbiota	Drug: Methimazole Pill Drug: Propylthiouracil Pill

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 Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Dec 23, 2017

Anticipated Primary Completion Date :

Dec 23, 2018

Anticipated Study Completion Date :

Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Control group 30 healthy volunteers were included in the healthy control group
Recrudescence group 30 GD patients who received recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill	Drug: Methimazole Pill Patients who developed GD received methimazole treatment Drug: Propylthiouracil Pill Patients who developed GD received propylthiouracil treatment
No recrudescence group 30 GD patients who did not receive recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill	Drug: Methimazole Pill Patients who developed GD received methimazole treatment Drug: Propylthiouracil Pill Patients who developed GD received propylthiouracil treatment

Arm

Intervention/Treatment

Control group

30 healthy volunteers were included in the healthy control group

Recrudescence group

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

Drug: Methimazole Pill

Patients who developed GD received methimazole treatment

Drug: Propylthiouracil Pill

Patients who developed GD received propylthiouracil treatment

No recrudescence group

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

Drug: Methimazole Pill

Patients who developed GD received methimazole treatment

Drug: Propylthiouracil Pill

Patients who developed GD received propylthiouracil treatment

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Serum thyroid related antibodies changed [Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal]
Serum thyroid related antibodies measured by Immunohistochemistry

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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