Gut Microbiota is Associated With Autoimmune Thyroid Disease

Gut Microbiota is Associated With Autoimmune Thyroid Disease(GD and HT)

Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's disease (GD), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. 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 AITD patients and healthy controls.

Study Overview

• Status: Unknown
• Conditions: Gut Microbiota
• Intervention / Treatment: Drug: Methimazole Pill

Detailed Description

Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's disease (GD), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. These two diseases are clinically diverse because in HT, T cells aid in the destruction of the thyroid epithelial cells (thyrocytes) and thyroid epithelial structure and eventual fibrous replacement of parenchymal tissue leading to hypothyroidism, whereas GD is primarily a humoral disease where auto-antibodies are generated against the thyroid stimulating hormone receptor (TSHR) leading to hyperthyroidism (2,163-165). However, these diseases still share several immunological features，and the disease may progress from one state to another as the autoimmune process evolves. 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 AITD patients and healthy controls.

• Study Type: Observational
• Enrollment (Anticipated): 200

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

Study Population are aged from 18 to 65 years，which divided into 4 groups:treatment-naive HT, treatment-naive GD, GD treated, healthy controls.

Description

Inclusion Criteria:

• Aged 18 to 65 years
• Male or female gender
• Euthyroidism (normal FT3, FT4, and TSH plasma levels without hormonal therapy)

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, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
• Known history of disease with an autoimmune component such as MS, rheumatoid arthritis, IBS, and IBD
• History of malignancy or any gastrointestinal tract surgery (e.g., gastrectomy, bariatric surgery, colectomy, ileectomy, cholecystectomy or appendectomy).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hashimoto's thyroiditis; Hashimoto's thyroiditis (HT) is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers.
healthy controls; healthy controls are all from normal volunteers
treatment_naive GD; GD is primarily a humoral disease where autoantibodies are generated against the thyroid stimulating hormone receptor (TSHR) leading to hyperthyroidism.
treated GD; GD patients treated by Methimazole Pill	Drug: Methimazole Pill; Hyperthyroidism patients are treated with Methimazole Pill according to the guidelines; Other Names: Methimazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
16S rRNAgene sequencing was used to measure the diversity of gut microbiota	Intestinal microbes are different in different groups	HC, treatment_naive HT and treatment_naive GD patients samples were collected at the enroll. Treated GD patients were collected until thyroid function resumed to the normal for at least 3 months of methimazole withdrawal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thyroid function tested by Chemiluminescence method	Serum results are different in different groups and different time point	Treatment_naive GD and treatment_naive HT patients thyroid function were tested at the enroll and after 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thyroid relative antibody test by Chemiluminescence	Serum results are different in different groups and different time point	Treatment_naive GD and treatment_naive HT patients thyroid function were tested at the enroll and after 3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Anticipated): December 24, 2018
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 28, 2017
• First Posted (Actual): January 4, 2018

Study Record Updates

• Last Update Posted (Actual): January 4, 2018
• Last Update Submitted That Met QC Criteria: December 28, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Gut Microbiota; Metabonomics; 16S rRNA gene; Graves' Disease; Methimazole; Hashimoto Thyroiditis; Levothyroxine sodium
• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Antithyroid Agents; Methimazole
• Other Study ID Numbers: Yunwei Wei 2017-12-14

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