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Gut Microbiota is Associated With Autoimmune Thyroid Disease

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

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Methimazole

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




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


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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).

Information from the National Library of Medicine

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


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

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

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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03390582     History of Changes
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

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