Change of Gut Microbiome in the Treatment of Graves' Disease

Graves' Disease Clinical Trial

Official title:

A Prospective Study Analyzing the Change of Gut Microbiome With Antithyroid Drug Treatment of Graves' Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04383795
• Other study ID #: KC19TESI0523
• Status: Completed
• Start date: May 19, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Graves' disease is the main cause of hyperthyroidism. Graves' disease has a prevalence of 0.5% in the general population. As a non-surgical treatment, antithyroid drug (ATD) and radioactive iodine treatment have been proposed and ATD is the first-line treatment in Korea. However, ATD has a rare but fatal side effect of agranulocytosis. Furthermore only half of its users maintain long-term remission and frequent recurrence is a problem to this disease. Therefore it is essential to distinguish between patients who respond well to ATD and those who resist it. The aim of this study is to verify the changes in gut microbiome in Graves' disease patients before and after six-month treatment with ATD. Patients first diagnosed with Graves' disease will participate in the study. The study design is a prospective longitudinal trial. The patients are asked to have their gut microbiome analyzed before and after the treatment of Graves' disease with ATD. Primary endpoint is the changes of analyzed gut microbiome before and after ATD treatment. Secondary outcome is to find species that can be used as a biomarker to differentiate the patients refractory to ATD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 69 Years

Eligibility

Inclusion Criteria:

• More than 19 years and lesser than 70 years

• First diagnosed as Graves' disease and planned to have antithyroid drug

Exclusion Criteria:

• Pregnancy and lactating women

• Inflammatory bowel disease

• Active malignancy

• Autoimmune disease

• Immune-deficiency patients

Related Conditions & MeSH terms

• Graves Disease
• Graves' Disease

Intervention

Drug:
• Antithyroid Drug
Administration of antithyroid Drug for 6 months

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of gut microbiome in the treatment of Graves' disease	Analysis of gut microbiome before and after treatment of Graves' disease with antithyroid drug	6 months after treatment