The Oral Microbiota is Associated With Autoimmune Thyroiditis

NCT03447093 | Unknown FDA Drug

• 1 other identifier: Yunwei Wei 2017 -12-23
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Autoimmune thyroiditis (AITD) mainly includes Hashimoto's thyroiditis (HT) and Grave's disease (GD). Studies have shown that autoimmune thyroiditis is closely related to microbial disorders such as autoimmune thyroiditis However, there is no report on the relationship between oral microecology and autoimmune thyroiditis. Therefore, our group will study the correlation between oral microbiota and AITD.

Conditions

Microbiota

Keywords

oral microbiota; 16S rRNA gene; Graves' disease; Methimazole; Propylthiouracil; Hashimoto's thyroiditis

Outcome Measures

Primary Outcomes (1)

• Transcriptional changes in oral microbiota

  The microbiota measured by 16S rRNA gene

  Baseline, 3 months, 6 months, 9 months, 12 months

Secondary Outcomes (1)

• Serum thyroid function changed

  Baseline, 3 months, 6 months, 9 months, 12 months

Other Outcomes (1)

• Serum thyroid related antibodies changed

  Baseline, 3 months, 6 months, 9 months, 12 months

Study Arms (4)

Control group

30 healthy volunteers were included in the healthy control group

Drug treatment group

30 GD patients who received treatment with Methimazole Pill or propylthiouracil pill

Drug: Methimazole Pill; Drug: Propylthiouracil Pill

Incipient group

30 untreated GD patients

Hashimoto's thyroiditis group

30 HT patients

Interventions

Methimazole Pill DRUG

Patients who developed GD received methimazole treatment

Drug treatment group

Propylthiouracil Pill DRUG

Patients who developed GD received propylthiouracil treatment

Drug treatment 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 thyroid function returned to normal
• HT was clinical diagnosed and thyroid function is 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 (3)

• Qin J, Li R, Raes J, Arumugam M, Burgdorf KS, Manichanh C, Nielsen T, Pons N, Levenez F, Yamada T, Mende DR, Li J, Xu J, Li S, Li D, Cao J, Wang B, Liang H, Zheng H, Xie Y, Tap J, Lepage P, Bertalan M, Batto JM, Hansen T, Le Paslier D, Linneberg A, Nielsen HB, Pelletier E, Renault P, Sicheritz-Ponten T, Turner K, Zhu H, Yu C, Li S, Jian M, Zhou Y, Li Y, Zhang X, Li S, Qin N, Yang H, Wang J, Brunak S, Dore J, Guarner F, Kristiansen K, Pedersen O, Parkhill J, Weissenbach J; MetaHIT Consortium; Bork P, Ehrlich SD, Wang J. A human gut microbial gene catalogue established by metagenomic sequencing. Nature. 2010 Mar 4;464(7285):59-65. doi: 10.1038/nature08821.

  PMID: 20203603 BACKGROUND

• Dewhirst FE, Chen T, Izard J, Paster BJ, Tanner AC, Yu WH, Lakshmanan A, Wade WG. The human oral microbiome. J Bacteriol. 2010 Oct;192(19):5002-17. doi: 10.1128/JB.00542-10. Epub 2010 Jul 23.

  PMID: 20656903 BACKGROUND

• Kabouridis PS, Pachnis V. Emerging roles of gut microbiota and the immune system in the development of the enteric nervous system. J Clin Invest. 2015 Mar 2;125(3):956-64. doi: 10.1172/JCI76308. Epub 2015 Mar 2.

  PMID: 25729852 BACKGROUND

MeSH Terms

Conditions

Graves Disease; Hashimoto Disease

Interventions

Methimazole; Propylthiouracil

Condition Hierarchy (Ancestors)

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

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 27, 2018
• Study Start: December 23, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2021
• Last Updated: February 27, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)