Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intestinal Microbiota and Treatment of GD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

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

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Effect of Intestinal Microbiota on Treatment Sensitivity and Prognosis of Methimazole for GD
Actual Study Start Date : December 23, 2017
Estimated Primary Completion Date : December 23, 2018
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Drug: Methimazole Pill
Patients who developed GD received methimazole treatment

Drug: Propylthiouracil Pill
Patients who developed GD received propylthiouracil treatment

No recrudescence group
30 GD patients who did not receive recurrence within 2 years after 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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

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): NCT03433352


Contacts
Layout table for location contacts
Contact: Yunwei Wei +86-0451-85553099 hydwyw11@hotmail.com

Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Yunwei Wei First Affiliated Hospital of Harbin Medical University

Publications:
Layout table for additonal information
Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03433352     History of Changes
Other Study ID Numbers: Yunwei Wei 2017-12-23
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
gut microbiota
16S rRNA gene
Graves' disease
Methimazole
Propylthiouracil
Additional relevant MeSH terms:
Layout table for MeSH terms
Propylthiouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antithyroid Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs