Intestinal Microbiota and Treatment of GD

Microbiota Clinical Trial

Official title:

The Effect of Intestinal Microbiota on Treatment Sensitivity and Prognosis of Methimazole for GD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03433352
• Other study ID #: Yunwei Wei 2017-12-23
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2018
• Last updated: February 13, 2018
• Start date: December 23, 2017
• Est. completion date: December 20, 2019

Study information

• Verified date: December 2017
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Yunwei Wei
• Phone: +86-0451-85553099
• Email: hydwyw11[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 20, 2019
• Est. primary completion date: December 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Microbiota

Intervention

Drug:
• Methimazole Pill
Patients who developed GD received methimazole treatment
• Propylthiouracil Pill
Patients who developed GD received propylthiouracil treatment

Locations

Country	Name	City	State
China	First affiliated hospital of Harbin medical university	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Calissendorff J, Mikulski E, Larsen EH, Möller M. A Prospective Investigation of Graves' Disease and Selenium: Thyroid Hormones, Auto-Antibodies and Self-Rated Symptoms. Eur Thyroid J. 2015 Jun;4(2):93-8. doi: 10.1159/000381768. Epub 2015 May 27. — View Citation

Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum thyroid related antibodies changed	Serum thyroid related antibodies measured by Immunohistochemistry	Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal
Primary	Transcriptional changes in gut microbiota	The microbiota measured by 16S rRNA gene	Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal
Secondary	Serum thyroid function changed	Serum thyroid function measured by Immunohistochemistry	Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal