Graves' DiseaseNCT04383795
Change of Gut Microbiome in the Treatment of Graves' Disease
An observational study of Graves' Disease, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Graves' Disease
- What is being tested?
- Antithyroid Drug
- How many people
- 29 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 May 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- More than 19 years and lesser than 70 years
- First diagnosed as Graves' disease and planned to have antithyroid drug
Who cannot join
- Pregnancy and lactating women
- Inflammatory bowel disease
- Active malignancy
- Autoimmune disease
- Immune-deficiency patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study Analyzing the Change of Gut Microbiome With Antithyroid Drug 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.
- Conditions
- Graves' Disease
- Being tested
- Antithyroid Drug
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithyroid DrugDrug
Administration of antithyroid Drug for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Graves' disease patients | First diagnosed Graves' disease patients volunteered for stool collection Receives: Drug: Antithyroid Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gut microbiome in the treatment of Graves' disease
Analysis of gut microbiome before and after treatment of Graves' disease with antithyroid drug
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start19 May 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Jun Lim, Seoul St. Mary's Hospital
- Investigators
- Dong-Jun Lim, MD, PhD, Principal investigator, the Catholic Univerisity of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383795
- Sponsor's protocol ID
- KC19TESI0523
- Status last verified
- Aug 2022
- First submitted
- 7 May 2020
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Analyzing the Change of Gut Microbiome With Antithyroid Drug Treatment of Graves' Disease
- ClinicalTrials.gov ID
- NCT04383795
- Acronym / sponsor ID
- KC19TESI0523
- Conditions
- Graves' Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 19 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Graves' disease patients | – | Drug: Antithyroid DrugFirst diagnosed Graves' disease patients volunteered for stool collection |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- More than 19 years and lesser than 70 years
- First diagnosed as Graves' disease and planned to have antithyroid drug
Key exclusion criteria (5 listed)
- Pregnancy and lactating women
- Inflammatory bowel disease
- Active malignancy
- Autoimmune disease
- Immune-deficiency patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antithyroid DrugAdministration of antithyroid Drug for 6 months | Drug | Graves' disease patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Graves' Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Jun Lim, MD, PhD principal investigator
the Catholic Univerisity of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves' Disease, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of gut microbiome in the treatment of Graves' disease (time frame: 6 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.