Change of Gut Microbiome in the Treatment of Graves' Disease

NCT ID: NCT04383795

Last Updated: 2022-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-19
• Study Completion Date: 2021-12-31

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.

Conditions

Graves' Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Graves' disease patients

First diagnosed Graves' disease patients volunteered for stool collection

Antithyroid Drug

Intervention Type: DRUG

Administration of antithyroid Drug for 6 months

Interventions

Antithyroid Drug

Administration of antithyroid Drug for 6 months

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong Jun Lim

Professor in Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong-Jun Lim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

the Catholic Univerisity of Korea

Locations

Seoul St. Mary hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

KC19TESI0523

Identifier Type: -

Identifier Source: org_study_id