Intestinal Microbiota and Treatment of GD

NCT ID: NCT03433352

Last Updated: 2018-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-23

Study Completion Date

2019-12-20

Brief Summary

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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

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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

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Microbiota

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control group

30 healthy volunteers were included in the healthy control group

No interventions assigned to this group

Recrudescence group

30 GD patients who received recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill

Methimazole Pill

Intervention Type DRUG

Patients who developed GD received methimazole treatment

Propylthiouracil Pill

Intervention Type DRUG

Patients who developed GD received propylthiouracil treatment

No recrudescence group

30 GD patients who did not receive recurrence within 2 years after treatment with Methimazole Pill or propylthiouracil pill

Methimazole Pill

Intervention Type DRUG

Patients who developed GD received methimazole treatment

Propylthiouracil Pill

Intervention Type DRUG

Patients who developed GD received propylthiouracil treatment

Interventions

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Methimazole Pill

Patients who developed GD received methimazole treatment

Intervention Type DRUG

Propylthiouracil Pill

Patients who developed GD received propylthiouracil treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yunwei Wei

Role: STUDY_DIRECTOR

First Affiliated Hospital of Harbin Medical University

Locations

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First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunwei Wei

Role: CONTACT

+86-0451-85553099

Facility Contacts

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Yunwei Wei

Role: primary

+86-0451-85553099

References

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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.

Reference Type BACKGROUND
PMID: 26279994 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26462967 (View on PubMed)

Other Identifiers

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Yunwei Wei 2017-12-23

Identifier Type: -

Identifier Source: org_study_id

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