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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04383795
Other study ID # KC19TESI0523
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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