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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04383795

Enrollment

Registered

2020-05-12

Start date

2020-05-19

Completion date

2021-12-31

Last updated

2022-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graves' Disease

Brief 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.

Interventions

DRUGAntithyroid Drug

Administration of antithyroid Drug for 6 months

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 69 Years

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026