Gut Microbiota is Associated With Autoimmune Thyroid Disease

• Conditions: Gut Microbiota
• Interventions: Drug: Methimazole Pill

• Registration Number: NCT03390582
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief Summary

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.

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 Timeline

• Study Start: 2017-04-20
• Status Verified: 2017-12
• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-28
• Last Update Submitted: 2017-12-28
• Study First Posted: 2018-01-04
• Last Update Posted: 2018-01-04
• Primary Completion: 2018-12-24
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
treated GD	Methimazole Pill	GD patients treated by Methimazole Pill

Primary Outcome Measures

Name	Time	Method
16S rRNAgene sequencing was used to measure the diversity of gut microbiota	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	Intestinal microbes are different in different groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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