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Intestinal Microbiota and Treatment of GD

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ClinicalTrials.gov Identifier: NCT03433352
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : February 14, 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 14, 2018
Last Update Posted Date February 14, 2018
Actual Study Start Date December 23, 2017
Estimated Primary Completion Date December 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2018)
Transcriptional changes in gut microbiota [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal ]
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 13, 2018)
Serum thyroid function changed [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal ]
Serum thyroid function measured by Immunohistochemistry
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 13, 2018)
Serum thyroid related antibodies changed [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal ]
Serum thyroid related antibodies measured by Immunohistochemistry
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Intestinal Microbiota and Treatment of GD
Official Title The Effect of Intestinal Microbiota on Treatment Sensitivity and Prognosis of Methimazole for GD
Brief Summary Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. 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 GD patients and healthy controls and analyse the relationship between intestinal microbiota and GD drug therapy.
Detailed Description Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. 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 GD patients and healthy controls before and found that gut microbiota changed between GD patients and healthy controls.But there are few articles on the relationship between intestinal microbiota and drug treatment of GD, so Investigators explored the relationship between intestinal microflora and methimazole treatment for GD.
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
  • Recrudescence group
    30 GD patients who received recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill
    Interventions:
    • Drug: Methimazole Pill
    • Drug: Propylthiouracil Pill
  • No recrudescence group
    30 GD patients who did not receive recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill
    Interventions:
    • Drug: Methimazole Pill
    • Drug: Propylthiouracil Pill
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 13, 2018)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 20, 2019
Estimated Primary Completion Date December 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Aged 18 to 65 years
  • GD was clinical diagnosed and accept the standard treatment of methimazole or propylthiouracil and thyroid function returned to 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 NCT03433352
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