NCT04383795

Change of Gut Microbiome in the Treatment of Graves' Disease

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graves' Disease

Interventions

Type	Name	Description
DRUG	Antithyroid Drug	Administration of antithyroid Drug for 6 months

Timeline

• Start date: 2020-05-19
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2020-05-12
• Last updated: 2022-08-12

Locations

1 site across 1 country: South Korea