Gut Microbiota is Associated With Autoimmune Thyroid Disease

• ClinicalTrials.gov Identifier: NCT03390582
• Recruitment Status: Recruiting
• First Posted: January 4, 2018
• Last Update Posted: January 4, 2018
• Sponsor: First Affiliated Hospital of Harbin Medical University
• Information provided by (Responsible Party): First Affiliated Hospital of Harbin Medical University

Study Description

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.

Condition or disease	Intervention/treatment
Gut Microbiota	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 Design

• Study Type: Observational
• Estimated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Gut Microbiota is Associated With Autoimmune Thyroid Disease(GD and HT)
• Actual Study Start Date: April 20, 2017
• Estimated Primary Completion Date: December 24, 2018
• Estimated Study Completion Date: November 1, 2021

Groups and Cohorts

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 Name: Methimazole

Outcome Measures

Primary Outcome Measures :

1. 16S rRNAgene sequencing was used to measure the diversity of gut microbiota [ Time Frame: 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 :

1. Thyroid function tested by Chemiluminescence method [ Time Frame: 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

Other Outcome Measures:

1. Thyroid relative antibody test by Chemiluminescence [ Time Frame: 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

Biospecimen Retention:   Samples With DNA

microbiota DNA are extracted from human feces

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• 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.

Criteria

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).

Contacts and Locations

Contacts

Contact: Wei Yunwei; +86-0451-85553099; hydwyw11@hotmail.com

Locations

China, Heilongjiang

First affiliated hospital of Harbin medical university; Recruiting

Harbin, Heilongjiang, China, 150001

Contact: Yunwei Wei +86-0451-85553099 hydwyw11@hotmail.com

Sponsors and Collaborators

First Affiliated Hospital of Harbin Medical University

Investigators

• Study Director: Wei Yunwei; First Affiliated Hospital of Harbin Medical University

More Information

• Responsible Party: First Affiliated Hospital of Harbin Medical University
• ClinicalTrials.gov Identifier: NCT03390582
• Other Study ID Numbers: Yunwei Wei 2017-12-14
• First Posted: January 4, 2018
• Last Update Posted: January 4, 2018
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital of Harbin Medical University:

Gut Microbiota; Hashimoto Thyroiditis; Graves' Disease; Methimazole; Levothyroxine sodium; 16S rRNA gene; Metabonomics

Additional relevant MeSH terms:

Thyroid Diseases; Endocrine System Diseases; Methimazole; Antithyroid Agents; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs