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Completed

NCT Number: NCT04383795

Change of Gut Microbiome in the Treatment of Graves' Disease

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.

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Key information

Age range

19 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul St. Mary hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antithyroid Drug

Drug

Administration of antithyroid Drug for 6 months

Primary outcomes

  1. Change of gut microbiome in the treatment of Graves' disease

    Time frame: 6 months after treatment

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

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 12, 2020
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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