Change of Gut Microbiome in the Treatment of Graves' Disease

NCT04383795 | Completed

• 1 other identifier: KC19TESI0523
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change of gut microbiome in the treatment of Graves' disease

  Analysis of gut microbiome before and after treatment of Graves' disease with antithyroid drug

  6 months after treatment

Study Arms (1)

Graves' disease patients

First diagnosed Graves' disease patients volunteered for stool collection

Drug: Antithyroid Drug

Interventions

Antithyroid Drug DRUG

Administration of antithyroid Drug for 6 months

Graves' disease patients

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients first diagnosed with Graves' disease, aged more than 19 years and lesser than 70 years. Eligible for treatment of graves' disease with antithyroid drug. Consented for collection of stools in 6-month interval

You may qualify if:

• More than 19 years and lesser than 70 years
• First diagnosed as Graves' disease and planned to have antithyroid drug

You may not qualify if:

• Pregnancy and lactating women
• Inflammatory bowel disease
• Active malignancy
• Autoimmune disease
• Immune-deficiency patients

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

Study Sites (1)

Seoul St. Mary hospital

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

stool sample from study participants before and after 6-month antithyroid drug treatment

MeSH Terms

Conditions

Graves Disease

Interventions

Antithyroid Agents

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Dong-Jun Lim, MD, PhD

  the Catholic Univerisity of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: May 19, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

KR (1)