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The Oral Microbiota is Associated With Autoimmune Thyroiditis

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ClinicalTrials.gov Identifier: NCT03447093
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

Brief Summary:
Autoimmune thyroiditis (AITD) mainly includes Hashimoto's thyroiditis (HT) and Grave's disease (GD). Studies have shown that autoimmune thyroiditis is closely related to microbial disorders such as autoimmune thyroiditis However, there is no report on the relationship between oral microecology and autoimmune thyroiditis. Therefore, our group will study the correlation between oral microbiota and AITD.

Condition or disease Intervention/treatment
Microbiota Drug: Methimazole Pill Drug: Propylthiouracil Pill

Detailed Description:
Autoimmune thyroiditis (AITD) mainly includes Hashimoto's thyroiditis (HT) and Grave's disease (GD). Studies have shown that autoimmune thyroiditis is closely related to microbiological disorders. Intestinal microelements Both ecology and oral microecology belong to the category of microorganisms. It has been reported in the literature that intestinal microecology occurs disorder of autoimmune thyroiditis. However, there is no report on the correlation between oral microecology and autoimmune thyroiditis. When oral microbe flora When the immune system is disrupted, the immune balance is broken, the immune system is over-active, and the autoimmune disease (AID) is lost to the autoantigens and non-pathogenic commensal microbial flora antigens, including rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, inflammatory bowel disease, and allergic diseases. However, the association between oral microbial flora and AITD remains unclear. . Therefore, the research group will carry out the correlation between oral microbial flora and AITD.

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Oral Microbiota in Autoimmune Thyroiditis is Distinctive And Predictive
Actual Study Start Date : December 23, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021


Group/Cohort Intervention/treatment
Control group
30 healthy volunteers were included in the healthy control group
Drug treatment group
30 GD patients who received treatment with Methimazole Pill or propylthiouracil pill
Drug: Methimazole Pill
Patients who developed GD received methimazole treatment

Drug: Propylthiouracil Pill
Patients who developed GD received propylthiouracil treatment

Incipient group
30 untreated GD patients
Hashimoto's thyroiditis group
30 HT patients



Primary Outcome Measures :
  1. Transcriptional changes in oral microbiota [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]
    The microbiota measured by 16S rRNA gene


Secondary Outcome Measures :
  1. Serum thyroid function changed [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]
    Serum thyroid function measured by Immunohistochemistry


Other Outcome Measures:
  1. Serum thyroid related antibodies changed [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]
    Serum thyroid related antibodies measured by Immunohistochemistry



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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
All patients were included according to the inclusion and exclusion criteria
Criteria

Inclusion Criteria:

  • Aged 18 to 65 years
  • GD was clinical diagnosed and thyroid function returned to normal
  • HT was clinical diagnosed and thyroid function is normal.

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, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
  • History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
  • History of malignancy or any gastrointestinal tract surgery

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): NCT03447093


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

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

Publications:
Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03447093     History of Changes
Other Study ID Numbers: Yunwei Wei 2017 -12-23
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: February 27, 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
Product Manufactured in and Exported from the U.S.: No

Keywords provided by First Affiliated Hospital of Harbin Medical University:
oral microbiota
16S rRNA gene
Graves' disease
Methimazole
Propylthiouracil
Hashimoto's thyroiditis

Additional relevant MeSH terms:
Thyroiditis
Thyroiditis, Autoimmune
Hashimoto Disease
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Propylthiouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antithyroid Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs