Intestinal Microbiota and Treatment of GD

NCT03433352 | Unknown FDA Drug

• 1 other identifier: Yunwei Wei 2017-12-23
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiota

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Transcriptional changes in gut microbiota

  The microbiota measured by 16S rRNA gene

  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

  Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal

Other Outcomes (1)

• Serum thyroid related antibodies changed

  Baseline, 3 months, 6 months, 9 months, 12 months, 18 months and 24 month respectively after Methimazole withdrawal

Study Arms (3)

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

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

Drug: Methimazole Pill; Drug: Propylthiouracil Pill

Interventions

Methimazole Pill DRUG

Patients who developed GD received methimazole treatment

No recrudescence group; Recrudescence group

Propylthiouracil Pill DRUG

Patients who developed GD received propylthiouracil treatment

No recrudescence group; Recrudescence group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients were included according to the inclusion and exclusion criteria

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 26279994 BACKGROUND

• 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.

  PMID: 26462967 BACKGROUND

MeSH Terms

Conditions

Graves Disease

Interventions

Methimazole; Propylthiouracil

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfhydryl Compounds; Sulfur Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiouracil; Uracil; Pyrimidinones; Pyrimidines

Study Officials

• Yunwei Wei

  First Affiliated Hospital of Harbin Medical University

  STUDY DIRECTOR

Central Study Contacts

Yunwei Wei

CONTACT

+86-0451-85553099; hydwyw11@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 14, 2018
• Study Start: December 23, 2017
• Primary Completion: December 23, 2018
• Study Completion: December 20, 2019
• Last Updated: February 14, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)