Intestinal Microbiota and Treatment of GD

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

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.

Study Overview

• Status: Unknown
• Conditions: Microbiota
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Recruiting
      • First Affiliated Hospital of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients were included according to the inclusion and exclusion criteria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Harbin Medical University
• Investigators: Study Director: Yunwei Wei, First Affiliated Hospital of Harbin Medical University

Publications and helpful links

General Publications

• Calissendorff J, Mikulski E, Larsen EH, Moller M. A Prospective Investigation of Graves' Disease and Selenium: Thyroid Hormones, Auto-Antibodies and Self-Rated Symptoms. Eur Thyroid J. 2015 Jun;4(2):93-8. doi: 10.1159/000381768. Epub 2015 May 27.
• Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2017
• Primary Completion (Anticipated): December 23, 2018
• Study Completion (Anticipated): December 20, 2019

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 13, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: gut microbiota; 16S rRNA gene; Graves' disease; Methimazole; Propylthiouracil
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Antithyroid Agents; Methimazole; Propylthiouracil
• Other Study ID Numbers: Yunwei Wei 2017-12-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No