Gut MicrobiotaNCT03390582
Gut Microbiota is Associated With Autoimmune Thyroid Disease
An observational study of Gut Microbiota, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's disease (GD), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota
- What is being tested?
- Methimazole Pill
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2017to 1 Nov 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study Population are aged from 18 to 65 years，which divided into 4 groups:treatment-naive HT, treatment-naive GD, GD treated, healthy controls.
Who may be able to join
- Aged 18 to 65 years
- Male or female gender
- Euthyroidism (normal FT3, FT4, and TSH plasma levels without hormonal therapy)
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, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine
- Known history of disease with an autoimmune component such as MS, rheumatoid arthritis, IBS, and IBD
- History of malignancy or any gastrointestinal tract surgery (e.g., gastrectomy, bariatric surgery, colectomy, ileectomy, cholecystectomy or appendectomy).
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: Gut Microbiota is Associated With Autoimmune Thyroid Disease(GD and HT)
Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's disease (GD), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. 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 AITD patients and healthy controls.
Read the detailed description
Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's disease (GD), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. These two diseases are clinically diverse because in HT, T cells aid in the destruction of the thyroid epithelial cells (thyrocytes) and thyroid epithelial structure and eventual fibrous replacement of parenchymal tissue leading to hypothyroidism, whereas GD is primarily a humoral disease where auto-antibodies are generated against the thyroid stimulating hormone receptor (TSHR) leading to hyperthyroidism (2,163-165). However, these diseases still share several immunological features，and the disease may progress from one state to another as the autoimmune process evolves. 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 AITD patients and healthy controls.
- Conditions
- Gut Microbiota
- Being tested
- Methimazole Pill
- Keywords
- Gut Microbiota, Hashimoto Thyroiditis, Graves' Disease, Methimazole, Levothyroxine sodium, 16S rRNA gene, Metabonomics
- Medical subject headings
- Hashimoto Disease, Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methimazole PillDrug
Also called Methimazole
Hyperthyroidism patients are treated with Methimazole Pill according to the guidelines
| Study group | Role | What they receive |
|---|---|---|
| Hashimoto's thyroiditis | Hashimoto's thyroiditis (HT) is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. | |
| healthy controls | healthy controls are all from normal volunteers | |
| treatment_naive GD | GD is primarily a humoral disease where autoantibodies are generated against the thyroid stimulating hormone receptor (TSHR) leading to hyperthyroidism. | |
| treated GD | GD patients treated by Methimazole Pill Receives: Drug: Methimazole Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
16S rRNAgene sequencing was used to measure the diversity of gut microbiota
Intestinal microbes are different in different groups
Measured: HC, treatment_naive HT and treatment_naive GD patients samples were collected at the enroll. Treated GD patients were collected until thyroid function resumed to the normal for at least 3 months of methimazole withdrawal
Secondary outcomes (1)
Thyroid function tested by Chemiluminescence method
Serum results are different in different groups and different time point
Measured: Treatment_naive GD and treatment_naive HT patients thyroid function were tested at the enroll and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start20 Apr 2017
- Primary completion24 Dec 2018 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Yunwei, Study director, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390582
- Sponsor's protocol ID
- Yunwei Wei 2017-12-14
- Status last verified
- Dec 2017
- First submitted
- 14 Dec 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota is Associated With Autoimmune Thyroid Disease(GD and HT)
- ClinicalTrials.gov ID
- NCT03390582
- Acronym / sponsor ID
- Yunwei Wei 2017-12-14
- Conditions
- Gut Microbiota
- Keywords
- Gut Microbiota, Hashimoto Thyroiditis, Graves' Disease, Methimazole, Levothyroxine sodium, 16S rRNA gene, Metabonomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 24 Dec 2018 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 4 Jan 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.
Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's disease (GD), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. 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 AITD patients and healthy controls.
Detailed description
Autoimmune thyroid disease (AITD), which includes Hashimoto's thyroiditis (HT) and Grave's disease (GD), are the most common organ-specific autoimmune diseases and affect more women than men, with a female-to-male ratio from 5 to 10. These two diseases are clinically diverse because in HT, T cells aid in the destruction of the thyroid epithelial cells (thyrocytes) and thyroid epithelial structure and eventual fibrous replacement of parenchymal tissue leading to hypothyroidism, whereas GD is primarily a humoral disease where auto-antibodies are generated against the thyroid stimulating hormone receptor (TSHR) leading to hyperthyroidism (2,163-165). However, these diseases still share several immunological features，and the disease may progress from one state to another as the autoimmune process evolves. 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 AITD patients and healthy controls.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hashimoto's thyroiditis | – | –Hashimoto's thyroiditis (HT) is an organ-specific autoimmune disease in which both genetic predisposition and environmental factors serve as disease triggers. |
| healthy controls | – | –healthy controls are all from normal volunteers |
| treatment_naive GD | – | –GD is primarily a humoral disease where autoantibodies are generated against the thyroid stimulating hormone receptor (TSHR) leading to hyperthyroidism. |
| treated GD | – | Drug: Methimazole PillGD patients treated by Methimazole Pill |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population are aged from 18 to 65 years，which divided into 4 groups:treatment-naive HT, treatment-naive GD, GD treated, healthy controls.
Key inclusion criteria (3 listed)
- Aged 18 to 65 years
- Male or female gender
- Euthyroidism (normal FT3, FT4, and TSH plasma levels without hormonal therapy)
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 PillAlso: MethimazoleHyperthyroidism patients are treated with Methimazole Pill according to the guidelines | Drug | treated GD |
Primary outcome
16S rRNAgene sequencing was used to measure the diversity of gut microbiota
Time frame: HC, treatment_naive HT and treatment_naive GD patients samples were collected at the enroll. Treated GD patients were collected until thyroid function resumed to the normal for at least 3 months of methimazole withdrawal
Intestinal microbes are different in different groups
1 secondary outcome
Thyroid function tested by Chemiluminescence method
Time frame: Treatment_naive GD and treatment_naive HT patients thyroid function were tested at the enroll and after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- 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.
Wei Yunwei 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 Gut 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 3 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 4 Jan 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 Wei Yunwei (+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?
16S rRNAgene sequencing was used to measure the diversity of gut microbiota (time frame: HC, treatment_naive HT and treatment_naive GD patients samples were collected at the enroll. Treated GD patients were collected until thyroid function resumed to the normal for at least 3 months of methimazole withdrawal). 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 4 Jan 2018.