ClinicalTrials.gg
Status unknownNCT03433352Updated Feb 14, 2018

Intestinal Microbiota and Treatment of GD

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 2018-02-14.

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has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.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
90
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies in Graves Disease with a site in China — 10 open to participants now, 10 under way, 1 of them phase 3. Graves Disease · China.

Started
2017
with 2 others
Observational
9 of 19
3 open now
Registered
6th of 19
by date
Lead sponsor
3 of 19
First Affiliated Hospital of Harbin Medical University

Among the 19 studies in Graves Disease with a site in China, this one is one of 3 that started in 2017, is one of 9 observational ones, and was the 6th registered.

Graves Disease

162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.

Browse Graves Disease studies →

Open to participants now

10 of the 19 studies in Graves Disease with a site in China are open now. Recruiting first, the newest first:

5 more — sign in →

All 10 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 39 Graves Disease studies recruiting now, 17 (44%) set no upper age limit and 20 (51%) stop at 75 or younger; 3 take children under 18; 7 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 19 studies in Graves Disease with a site in China, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Microbiota

Browse trials for

Keywords

  • gut microbiota
  • 16S rRNA gene
  • Graves' disease
  • Methimazole
  • Propylthiouracil
04

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Cigarette smoking
  • Alcohol addiction
  • Hypertension
  • Diabetes mellitus
  • Lipid dysregulation
  • > 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 component, such as MS, rheumatoid arthritis, IBS, or IBD
  • History of or any gastrointestinal tract surgery
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

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

Groups and cohorts

  • 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

  • DrugMethimazole Pill

    Patients who developed GD received methimazole treatment

  • DrugPropylthiouracil Pill

    Patients who developed GD received propylthiouracil treatment

06

What researchers measure

Primary outcomes

  1. Transcriptional changes in gut microbiota

    The microbiota measured by 16S rRNA gene

    Time frame: 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

    Serum thyroid function measured by Immunohistochemistry

    Time frame: 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

    Serum thyroid related antibodies measured by Immunohistochemistry

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

07

Study locations

1 of 1 sites recruiting
  • First affiliated hospital of Harbin medical university
    Harbin, Heilongjiang 150001, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26279994 ↗
  • 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. PubMed 26462967 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2017 (actual). Primary completion is estimated for Dec 2018, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 8, 2018
First posted
Feb 14, 2018
StartActual
Dec 23, 2017
Primary completionEst.
Dec 23, 2018
CompletionEst.
Dec 20, 2019
Last update
Feb 14, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03433352
Lead sponsor
First Affiliated Hospital of Harbin Medical University
Responsible party
Sponsor
First posted
Feb 14, 2018
Start date
Dec 23, 2017
Primary completion
Dec 23, 2018 (estimated)
Completion
Dec 20, 2019 (estimated)
Last update
Feb 14, 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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Discussion

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