Gut Microbiota is Associated With Autoimmune Thyroid Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03390582 |
Recruitment Status :
Recruiting
First Posted : January 4, 2018
Last Update Posted : January 4, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Gut Microbiota | Drug: Methimazole Pill |
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 |

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 |
- 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
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390582
Contact: Wei Yunwei | +86-0451-85553099 | hydwyw11@hotmail.com |
China, Heilongjiang | |
First affiliated hospital of Harbin medical university | Recruiting |
Harbin, Heilongjiang, China, 150001 | |
Contact: Yunwei Wei +86-0451-85553099 hydwyw11@hotmail.com |
Study Director: | Wei Yunwei | First Affiliated Hospital of Harbin Medical University |
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 Key Record Dates |
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 |
Gut Microbiota Hashimoto Thyroiditis Graves' Disease Methimazole |
Levothyroxine sodium 16S rRNA gene Metabonomics |
Thyroid Diseases Endocrine System Diseases Methimazole Antithyroid Agents |
Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |