Gut Microbiota is Associated With Autoimmune Thyroid Disease

NCT ID: NCT03390582

Last Updated: 2018-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-20

Study Completion Date

2021-11-01

Brief Summary

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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

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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.

Conditions

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Gut Microbiota

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

healthy controls

healthy controls are all from normal volunteers

No interventions assigned to this group

treatment_naive GD

GD is primarily a humoral disease where autoantibodies are generated against the thyroid stimulating hormone receptor (TSHR) leading to hyperthyroidism.

No interventions assigned to this group

treated GD

GD patients treated by Methimazole Pill

Methimazole Pill

Intervention Type DRUG

Hyperthyroidism patients are treated with Methimazole Pill according to the guidelines

Interventions

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Methimazole Pill

Hyperthyroidism patients are treated with Methimazole Pill according to the guidelines

Intervention Type DRUG

Other Intervention Names

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Methimazole

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wei Yunwei

Role: STUDY_DIRECTOR

First Affiliated Hospital of Harbin Medical University

Locations

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First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Yunwei

Role: CONTACT

+86-0451-85553099

Facility Contacts

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Yunwei Wei

Role: primary

+86-0451-85553099

Other Identifiers

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Yunwei Wei 2017-12-14

Identifier Type: -

Identifier Source: org_study_id

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