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NCT04383795
Change of Gut Microbiome in the Treatment of Graves' Disease
trial testing Antithyroid Drug in Graves' Disease in 29 participants. Completed in 31 December 2021.
31 December 2021
Quick facts
| Lead sponsor | Seoul St. Mary's Hospital |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 29 |
| Start date | 19 May 2020 |
| Primary completion | 31 December 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- Antithyroid Drug — full drug profile →
Conditions studied
- Graves' Disease — all drugs for Graves' Disease →
Sponsor
Seoul St. Mary's Hospital
Who can join
Adults 19 to 69, any sex, with Graves' Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Gut microbiome in the Graves' disease: Comparison before and after anti-thyroid drug treatment.
Jeong C, Baek H, Bae J, Hwang N, et al · · 2024 · cited 6× · PMID 38820506 · DOI 10.1371/journal.pone.0300678
Verify or expand the search:
- PubMed search for NCT04383795
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other trials of Antithyroid Drug
Trials testing the same drug.
- NCT03066076 — Total Thyroidectomy Versus Thionamides in Patients With Moderate-to-Severe Graves' Ophthalmopathy · Phase 3 · unknown
Other recruiting trials for Graves' Disease
Currently open trials in the same condition.
- NCT06984627 — A Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease · Phase 2 · recruiting
- NCT07369063 — Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease · Phase 2 · recruiting
- NCT06068179 — Graves' Disease Remission Study: MycoMeth Combo · Phase 2, PHASE3 · recruiting
Other Seoul St. Mary's Hospital trials
Trials by the same sponsor.
- NCT07345026 — Acellular Dermal Matrix(SureDerm BCS) in Breast-Conserving Surgery for Breast Cancer Patients · NA · not yet recruiting
- NCT07380867 — Confirming the Accuracy of Endoscopic Marking Using a New Marker, a Novel Luminomarker, in Lesion Marking Before Colorec · NA · enrolling by invitation
- NCT07240844 — Enavogliflozin for the Management of Patients With Amyloid CardiomyopaThy · Phase 4 · not yet recruiting
- NCT06769087 — Comparing Immediate Removal and Postoperative 1 Day of Urinary Catheter After Colorectal Cancer Surgery · NA · enrolling by invitation
- NCT06442111 — The Role of Intravenous Ferritin in Optimizing Postoperative Recovery Following Pancreaticoduodenectomy · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04383795 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Seoul St. Mary's Hospital
- Last refreshed: 12 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04383795.
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