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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

Tracking Information
First Submitted Date February 8, 2018
First Posted Date February 27, 2018
Last Update Posted Date February 27, 2018
Actual Study Start Date December 23, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2018)
Transcriptional changes in oral microbiota [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]
The microbiota measured by 16S rRNA gene
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: February 25, 2018)
Serum thyroid function changed [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]
Serum thyroid function measured by Immunohistochemistry
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 25, 2018)
Serum thyroid related antibodies changed [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]
Serum thyroid related antibodies measured by Immunohistochemistry
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title The Oral Microbiota is Associated With Autoimmune Thyroiditis
Official Title The Oral Microbiota in Autoimmune Thyroiditis is Distinctive And Predictive
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All patients were included according to the inclusion and exclusion criteria
Condition Microbiota
Intervention
  • Drug: Methimazole Pill
    Patients who developed GD received methimazole treatment
  • Drug: Propylthiouracil Pill
    Patients who developed GD received propylthiouracil treatment
Study Groups/Cohorts
  • 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
    Interventions:
    • Drug: Methimazole Pill
    • Drug: Propylthiouracil Pill
  • Incipient group
    30 untreated GD patients
  • Hashimoto's thyroiditis group
    30 HT patients
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 25, 2018)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Yunwei Wei +86-0451-85553099 hydwyw11@hotmail.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03447093
Other Study ID Numbers Yunwei Wei 2017 -12-23
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party First Affiliated Hospital of Harbin Medical University
Study Sponsor First Affiliated Hospital of Harbin Medical University
Collaborators Not Provided
Investigators
Study Director: Yunwei Wei First Affiliated Hospital of Harbin Medical University
PRS Account First Affiliated Hospital of Harbin Medical University
Verification Date December 2017