MicrobiotaNCT03433352
Intestinal Microbiota and Treatment of GD
An observational study of Microbiota, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota
- What is being tested?
- Methimazole Pill and Propylthiouracil Pill
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 23 Dec 2017to 20 Dec 2019
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients were included according to the inclusion and exclusion criteria
Who may be able to join
- Aged 18 to 65 years
- GD was clinical diagnosed and accept the standard treatment of methimazole or propylthiouracil and thyroid function returned to normal
Who cannot join
- Pregnancy
- Lactation
- Cigarette smoking
- Alcohol addiction
- Hypertension
- Diabetes mellitus
Show all 11Show fewer
- Lipid dysregulation
- BMI > 27
- Recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
- History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD
- History of malignancy or any gastrointestinal tract surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001
Yunwei Wei, +86-0451-85553099, hydwyw11@hotmail.com
About this study
Official title: The Effect of Intestinal Microbiota on Treatment Sensitivity and Prognosis of Methimazole for GD
Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in GD patients and healthy controls and analyse the relationship between intestinal microbiota and GD drug therapy.
Read the detailed description
Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in GD patients and healthy controls before and found that gut microbiota changed between GD patients and healthy controls.But there are few articles on the relationship between intestinal microbiota and drug treatment of GD, so Investigators explored the relationship between intestinal microflora and methimazole treatment for GD.
- Conditions
- Microbiota
- Being tested
- Methimazole Pill, Propylthiouracil Pill
- Keywords
- gut microbiota, 16S rRNA gene, Graves' disease, Methimazole, Propylthiouracil
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methimazole PillDrug
Patients who developed GD received methimazole treatment
Propylthiouracil PillDrug
Patients who developed GD received propylthiouracil treatment
| Study group | Role | What they receive |
|---|---|---|
| Control group | 30 healthy volunteers were included in the healthy control group | |
| Recrudescence group | 30 GD patients who received recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill Receives: Drug: Methimazole Pill; Drug: Propylthiouracil Pill | |
| No recrudescence group | 30 GD patients who did not receive recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill Receives: Drug: Methimazole Pill; Drug: Propylthiouracil Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptional changes in gut microbiota
The microbiota measured by 16S rRNA gene
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal
Secondary outcomes (1)
Serum thyroid function changed
Serum thyroid function measured by Immunohistochemistry
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start23 Dec 2017
- Primary completion23 Dec 2018 (estimated)
- Study completion20 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MicrobiotaStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunwei Wei, Study director, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433352
- Sponsor's protocol ID
- Yunwei Wei 2017-12-23
- Status last verified
- Dec 2017
- First submitted
- 8 Feb 2018
- Last updated
- 14 Feb 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calissendorff J, Mikulski E, Larsen EH, Moller M. A Prospective Investigation of Graves' Disease and Selenium: Thyroid Hormones, Auto-Antibodies and Self-Rated Symptoms. Eur Thyroid J. 2015 Jun;4(2):93-8. doi: 10.1159/000381768. Epub 2015 May 27.
PubMed 26279994Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
PubMed 26462967
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intestinal Microbiota on Treatment Sensitivity and Prognosis of Methimazole for GD
- ClinicalTrials.gov ID
- NCT03433352
- Acronym / sponsor ID
- Yunwei Wei 2017-12-23
- Conditions
- Microbiota
- Keywords
- gut microbiota, 16S rRNA gene, Graves' disease, Methimazole, Propylthiouracil
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 23 Dec 2017 (actual)
- Primary completion
- 23 Dec 2018 (estimated)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 14 Feb 2018 (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 an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in GD patients and healthy controls and analyse the relationship between intestinal microbiota and GD drug therapy.
Detailed description
Graves' disease is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. Many studies have indicated that alterations in the gut microbiota are important environmental factors in the development of inflammatory and autoimmune diseases. Investigators systematically performed a comparative analysis of the gut microbiota in GD patients and healthy controls before and found that gut microbiota changed between GD patients and healthy controls.But there are few articles on the relationship between intestinal microbiota and drug treatment of GD, so Investigators explored the relationship between intestinal microflora and methimazole treatment for GD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –30 healthy volunteers were included in the healthy control group |
| Recrudescence group | – | Drug: Methimazole Pill, Drug: Propylthiouracil Pill30 GD patients who received recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill |
| No recrudescence group | – | Drug: Methimazole Pill, Drug: Propylthiouracil Pill30 GD patients who did not receive recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were included according to the inclusion and exclusion criteria
Key inclusion criteria (2 listed)
- Aged 18 to 65 years
- GD was clinical diagnosed and accept the standard treatment of methimazole or propylthiouracil and thyroid function returned to normal
Key exclusion criteria (11 listed)
- Pregnancy
- Lactation
- Cigarette smoking
- Alcohol addiction
- Hypertension
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 |
|---|---|---|
| Methimazole PillPatients who developed GD received methimazole treatment | Drug | No recrudescence group, Recrudescence group |
| Propylthiouracil PillPatients who developed GD received propylthiouracil treatment | Drug | No recrudescence group, Recrudescence group |
Primary outcome
Transcriptional changes in gut microbiota
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal
The microbiota measured by 16S rRNA gene
1 secondary outcome
Serum thyroid function changed
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Background: PubMed 26279994Calissendorff J, Mikulski E, Larsen EH, Moller M. A Prospective Investigation of Graves' Disease and Selenium: Thyroid Hormones, Auto-Antibodies and Self-Rated Symptoms. Eur Thyroid J. 2015 Jun;4(2):93-8. doi: 10.1159/000381768. Epub 2015 May 27.
- Background: PubMed 26462967Haugen BR, Alexander EK, Bible KC, Doherty GM, Mandel SJ, Nikiforov YE, Pacini F, Randolph GW, Sawka AM, Schlumberger M, Schuff KG, Sherman SI, Sosa JA, Steward DL, Tuttle RM, Wartofsky L. 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer. Thyroid. 2016 Jan;26(1):1-133. doi: 10.1089/thy.2015.0020.
- Individual participant dataSharing planned: No
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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.
Yunwei Wei study director
First Affiliated Hospital of Harbin Medical University
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 Microbiota, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
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 11 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: status not confirmed, as of the sponsor's last update on 14 Feb 2018. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunwei Wei (+86-0451-85553099, hydwyw11@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptional changes in gut microbiota (time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03433352, which also lists 2 linked publications.
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 14 Feb 2018.