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Change of Gut Microbiome in the Treatment of Graves' Disease

S

Seoul St. Mary's Hospital

Status

Completed

Conditions

Graves' Disease

Treatments

Drug: Antithyroid Drug

Study type

Observational

Funder types

Other

Identifiers

NCT04383795
KC19TESI0523

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

19 to 69 years old

Volunteers

No Healthy Volunteers

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

Trial design

29 participants in 1 patient group

Graves' disease patients
Description:
First diagnosed Graves' disease patients volunteered for stool collection
Treatment:
Drug: Antithyroid Drug

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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