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Status unknownNCT03447093Updated Feb 27, 2018

The Oral Microbiota is Associated With Autoimmune Thyroiditis

An observational study in Microbiota, sponsored by First Affiliated Hospital of Harbin Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-27.

Sponsored by First Affiliated Hospital of Harbin Medical University · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Autoimmune thyroiditis (AITD) mainly includes Hashimoto's thyroiditis (HT) and Grave's disease (GD). Studies have shown that autoimmune thyroiditis is closely related to microbiological disorders. Intestinal microelements Both ecology and oral microecology belong to the category of microorganisms. It has been reported in the literature that intestinal microecology occurs disorder of autoimmune thyroiditis. However, there is no report on the correlation between oral microecology and autoimmune thyroiditis. When oral microbe flora When the immune system is disrupted, the immune balance is broken, the immune system is over-active, and the autoimmune disease (AID) is lost to the autoantigens and non-pathogenic commensal microbial flora antigens, including rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, inflammatory bowel disease, and allergic diseases. However, the association between oral microbial flora and AITD remains unclear. . Therefore, the research group will carry out the correlation between oral microbial flora and AITD.

02

Conditions studied

  • Microbiota

Keywords

  • oral microbiota
  • 16S rRNA gene
  • Graves' disease
  • Methimazole
  • Propylthiouracil
  • Hashimoto's thyroiditis
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

All patients were included according to the inclusion and exclusion criteria

Inclusion criteria

  • Aged 18 to 65 years
  • GD was clinical diagnosed and thyroid function returned to normal
  • HT was clinical diagnosed and thyroid function is normal.

Exclusion criteria

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
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DrugMethimazole Pill

    Patients who developed GD received methimazole treatment

  • DrugPropylthiouracil Pill

    Patients who developed GD received propylthiouracil treatment

05

What researchers measure

Primary outcomes

  1. Transcriptional changes in oral microbiota

    The microbiota measured by 16S rRNA gene

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months

Secondary outcomes

  1. Serum thyroid function changed

    Serum thyroid function measured by Immunohistochemistry

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months

Other outcomes

  1. Serum thyroid related antibodies changed

    Serum thyroid related antibodies measured by Immunohistochemistry

    Time frame: Baseline, 3 months, 6 months, 9 months, 12 months

06

Study locations

1 of 1 sites recruiting
  • First affiliated hospital of Harbin medical university
    Harbin, Heilongjiang 150001, China
    Recruiting
07

References and documents

Publications

  • 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. PubMed 20203603 ↗
  • 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. PubMed 20656903 ↗
  • 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. PubMed 25729852 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03447093
Lead sponsor
First Affiliated Hospital of Harbin Medical University
Responsible party
Sponsor
First posted
Feb 27, 2018
Start date
Dec 23, 2017
Primary completion
Dec 2019 (estimated)
Completion
Dec 2021 (estimated)
Last update
Feb 27, 2018

Study contacts

Yunwei Wei
Contact
hydwyw11@hotmail.com
+86-0451-85553099
Yunwei Wei
study director · First Affiliated Hospital of Harbin Medical University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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