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Intestinal Microbiota and Treatment of GD

The Effect of Intestinal Microbiota on Treatment Sensitivity and Prognosis of Methimazole for GD

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03433352
Enrollment
90
Registered
2018-02-14
Start date
2017-12-23
Completion date
2019-12-20
Last updated
2018-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbiota

Keywords

gut microbiota, 16S rRNA gene, Graves' disease, Methimazole, Propylthiouracil

Brief 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. 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.

Interventions

Patients who developed GD received methimazole treatment

Patients who developed GD received propylthiouracil treatment

Sponsors

First Affiliated Hospital of Harbin Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged 18 to 65 years * GD was clinical diagnosed and accept the standard treatment of methimazole or propylthiouracil and thyroid function returned to normal

Exclusion criteria

* Pregnancy * Lactation * Cigarette smoking * Alcohol addiction * Hypertension * Diabetes mellitus * 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

Design outcomes

Primary

MeasureTime frameDescription
Transcriptional changes in gut microbiotaBaseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawalThe microbiota measured by 16S rRNA gene

Secondary

MeasureTime frameDescription
Serum thyroid function changedBaseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawalSerum thyroid function measured by Immunohistochemistry

Other

MeasureTime frameDescription
Serum thyroid related antibodies changedBaseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawalSerum thyroid related antibodies measured by Immunohistochemistry

Countries

China

Contacts

Primary ContactYunwei Wei
hydwyw11@hotmail.com+86-0451-85553099

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026