Gut Microbiota is Associated With Autoimmune Thyroid Disease

NCT03390582 | Unknown FDA Drug

• 1 other identifier: Yunwei Wei 2017-12-14
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiota

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• Thyroid relative antibody test by Chemiluminescence

  Treatment_naive GD and treatment_naive HT patients thyroid function were tested at the enroll and after 3 months

Study Arms (4)

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

Interventions

Methimazole Pill DRUG

Hyperthyroidism patients are treated with Methimazole Pill according to the guidelines

Also known as: Methimazole

treated GD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

microbiota DNA are extracted from human feces

MeSH Terms

Conditions

Hashimoto Disease; Graves Disease

Interventions

Methimazole

Condition Hierarchy (Ancestors)

Thyroiditis, Autoimmune; Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Hyperthyroidism

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wei Yunwei

  First Affiliated Hospital of Harbin Medical University

  STUDY DIRECTOR

Central Study Contacts

Wei Yunwei

CONTACT

+86-0451-85553099; hydwyw11@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 4, 2018
• Study Start: April 20, 2017
• Primary Completion: December 24, 2018
• Study Completion: November 1, 2021
• Last Updated: January 4, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)