Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT03447093
Status:
UNKNOWN
Last Update Posted:
2018-02-27
First Post:
2018-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Oral Microbiota is Associated With Autoimmune Thyroiditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D050031', 'term': 'Hashimoto Disease'}], 'ancestors': [{'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D013967', 'term': 'Thyroiditis, Autoimmune'}, {'id': 'D013966', 'term': 'Thyroiditis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008713', 'term': 'Methimazole'}, {'id': 'D011441', 'term': 'Propylthiouracil'}], 'ancestors': [{'id': 'D013438', 'term': 'Sulfhydryl Compounds'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013889', 'term': 'Thiouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-25', 'studyFirstSubmitDate': '2018-02-08', 'studyFirstSubmitQcDate': '2018-02-25', 'lastUpdatePostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum thyroid related antibodies changed', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'Serum thyroid related antibodies measured by Immunohistochemistry'}], 'primaryOutcomes': [{'measure': 'Transcriptional changes in oral microbiota', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'The microbiota measured by 16S rRNA gene'}], 'secondaryOutcomes': [{'measure': 'Serum thyroid function changed', 'timeFrame': 'Baseline, 3 months, 6 months, 9 months, 12 months', 'description': 'Serum thyroid function measured by Immunohistochemistry'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oral microbiota', '16S rRNA gene', "Graves' disease", 'Methimazole', 'Propylthiouracil', "Hashimoto's thyroiditis"], 'conditions': ['Microbiota']}, 'referencesModule': {'references': [{'pmid': '20203603', 'type': 'BACKGROUND', 'citation': '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': '20656903', 'type': 'BACKGROUND', 'citation': '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': '25729852', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients were included according to the inclusion and exclusion criteria', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 to 65 years\n* GD was clinical diagnosed and thyroid function returned to normal\n* HT was clinical diagnosed and thyroid function is normal.\n\nExclusion Criteria:\n\n* Pregnancy\n* Lactation\n* Cigarette smoking\n* Alcohol addiction\n* Hypertension\n* Diabetes mellitus\n* Lipid dysregulation\n* BMI \\> 27\n* Recent (\\< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or Chinese herbal medicine\n* History of disease with an autoimmune component, such as MS, rheumatoid arthritis, IBS, or IBD\n* History of malignancy or any gastrointestinal tract surgery'}, 'identificationModule': {'nctId': 'NCT03447093', 'briefTitle': 'The Oral Microbiota is Associated With Autoimmune Thyroiditis', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Harbin Medical University'}, 'officialTitle': 'The Oral Microbiota in Autoimmune Thyroiditis is Distinctive And Predictive', 'orgStudyIdInfo': {'id': 'Yunwei Wei 2017 -12-23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': '30 healthy volunteers were included in the healthy control group'}, {'label': 'Drug treatment group', 'description': '30 GD patients who received treatment with Methimazole Pill or propylthiouracil pill', 'interventionNames': ['Drug: Methimazole Pill', 'Drug: Propylthiouracil Pill']}, {'label': 'Incipient group', 'description': '30 untreated GD patients'}, {'label': "Hashimoto's thyroiditis group", 'description': '30 HT patients'}], 'interventions': [{'name': 'Methimazole Pill', 'type': 'DRUG', 'description': 'Patients who developed GD received methimazole treatment', 'armGroupLabels': ['Drug treatment group']}, {'name': 'Propylthiouracil Pill', 'type': 'DRUG', 'description': 'Patients who developed GD received propylthiouracil treatment', 'armGroupLabels': ['Drug treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunwei Wei', 'role': 'CONTACT', 'email': 'hydwyw11@hotmail.com', 'phone': '+86-0451-85553099'}], 'facility': 'First affiliated hospital of Harbin medical university', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'centralContacts': [{'name': 'Yunwei Wei', 'role': 'CONTACT', 'email': 'hydwyw11@hotmail.com', 'phone': '+86-0451-85553099'}], 'overallOfficials': [{'name': 'Yunwei Wei', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Harbin Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}