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Gut Microbiota is Associated With Autoimmune Thyroid Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03390582
Enrollment
200
Registered
2018-01-04
Start date
2017-04-20
Completion date
2021-11-01
Last updated
2018-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiota

Keywords

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

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.

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.

Interventions

Hyperthyroidism patients are treated with Methimazole Pill according to the guidelines

Sponsors

First Affiliated Hospital of Harbin Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
16S rRNAgene sequencing was used to measure the diversity of gut microbiotaHC, 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 withdrawalIntestinal microbes are different in different groups

Secondary

MeasureTime frameDescription
Thyroid function tested by Chemiluminescence methodTreatment_naive GD and treatment_naive HT patients thyroid function were tested at the enroll and after 3 monthsSerum results are different in different groups and different time point

Other

MeasureTime frameDescription
Thyroid relative antibody test by ChemiluminescenceTreatment_naive GD and treatment_naive HT patients thyroid function were tested at the enroll and after 3 monthsSerum results are different in different groups and different time point

Countries

China

Contacts

Primary ContactWei Yunwei
hydwyw11@hotmail.com+86-0451-85553099

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026