Change of Gut Microbiome in the Treatment of Graves' Disease

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Seoul St. Mary's Hospital
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Updated on 5 August 2020
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remission
hyperthyroidism
graves' disease
antithyroid drugs

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.

Details
Condition GRAVES' DISEASE
Age 19years - 69years
Treatment Antithyroid Drug
Clinical Study IdentifierNCT04383795
SponsorSeoul St. Mary's Hospital
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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
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