Clinical trial NCT03433352: Intestinal Microbiota and Treatment of GD
Official title: The Effect of Intestinal Microbiota on Treatment Sensitivity and Prognosis of Methimazole for GD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbiota
Keywords: gut microbiota
16S rRNA gene
Graves' disease
Methimazole
Propylthiouracil
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients were included according to the inclusion and exclusion criteria

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.

Eligibility criteria: 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

Primary outcomes:
measure: Transcriptional changes in gut microbiota
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal
Secondary outcomes:
measure: Serum thyroid function changed
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal
Other outcomes:
measure: Serum thyroid related antibodies changed
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal
Locations:
city: Harbin
country: China
facility: First affiliated hospital of Harbin medical university
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Yunwei Wei
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Haugen 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.