Gut Microbiota is Associated With Autoimmune Thyroid Disease

Gut Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03390582
• Other study ID #: Yunwei Wei 2017-12-14
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2017
• Last updated: December 28, 2017
• Start date: April 20, 2017
• Est. completion date: November 1, 2021

Study information

• Verified date: December 2017
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Wei Yunwei
• Phone: +86-0451-85553099
• Email: hydwyw11[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 1, 2021
• Est. primary completion date: December 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Gut Microbiota
• Thyroid Diseases

Intervention

Drug:
• Methimazole Pill
Hyperthyroidism patients are treated with Methimazole Pill according to the guidelines

Locations

Country	Name	City	State
China	First affiliated hospital of Harbin medical university	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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