Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2026-01-29 @ 2:44 PM
Study NCT ID:
NCT03151850
Status:
UNKNOWN
Last Update Posted:
2017-05-12
First Post:
2016-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Different Degree of Inflammation of Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2016-12-19', 'studyFirstSubmitQcDate': '2017-05-10', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fungus detection rate', 'timeFrame': '6 months', 'description': 'Fungi detection rate was defined as the percentage of patients in whose colonic mucosa at least one kind of fungus were identified.'}, {'measure': 'yeasts detection rate', 'timeFrame': '6 months', 'description': 'Yeasts detection rate was defined as the percentage of patients in whose colonic mucosa yeasts were identified.'}, {'measure': 'candida albicans detection rate', 'timeFrame': '6 months', 'description': 'Candida albicans detection rate was defined as the percentage of patients in whose colonic mucosa candida albicans were identified.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fungal', 'mucosa', 'diversity', 'Basidiomycete'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '26843508', 'type': 'RESULT', 'citation': 'Sokol H, Leducq V, Aschard H, Pham HP, Jegou S, Landman C, Cohen D, Liguori G, Bourrier A, Nion-Larmurier I, Cosnes J, Seksik P, Langella P, Skurnik D, Richard ML, Beaugerie L. Fungal microbiota dysbiosis in IBD. Gut. 2017 Jun;66(6):1039-1048. doi: 10.1136/gutjnl-2015-310746. Epub 2016 Feb 3.'}, {'pmid': '25522934', 'type': 'RESULT', 'citation': 'Mukhopadhya I, Hansen R, Meharg C, Thomson JM, Russell RK, Berry SH, El-Omar EM, Hold GL. The fungal microbiota of de-novo paediatric inflammatory bowel disease. Microbes Infect. 2015 Apr;17(4):304-10. doi: 10.1016/j.micinf.2014.12.001. Epub 2014 Dec 15.'}, {'pmid': '23882266', 'type': 'RESULT', 'citation': 'Eriksson M, Johannssen T, von Smolinski D, Gruber AD, Seeberger PH, Lepenies B. The C-Type Lectin Receptor SIGNR3 Binds to Fungi Present in Commensal Microbiota and Influences Immune Regulation in Experimental Colitis. Front Immunol. 2013 Jul 16;4:196. doi: 10.3389/fimmu.2013.00196. eCollection 2013.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed?term=fungal%20microbiota%20disbiosis%20in%20ibd&cmd=correctspelling', 'label': 'PUBmed'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/?term=The+fungal+microbiota+of+de-novo+paediatric+inflammatory+bowel+disease', 'label': 'pubmed'}]}, 'descriptionModule': {'briefSummary': 'We analyzed the diversity of the fungal and bacterial within colon mucosa between patients with different degree of inflammation of Ulcerative Colitis.', 'detailedDescription': 'In recent years, the relationship of intestinal fungus with inflammatory bowel disease was gradually revealed. We divided the patients with ulcerative colitis into three groups on the basis of World Gastroenterology Organisation (WGO) classification about inflammation degree and progress classification and established the healthy control group. Analyzing the diversity of the fungal and bacterial within colon mucosa between patients with different clinical classification, for example, the proportion of bacteria and fungi, the proportion of candida albicans, the proportion of yeasts, and so on.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients under endoscopic surveillance or examination at Qilu Hospital were considered for inclusion.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients at our tertiary care medical center, aged between 18 and 80 years, scheduled to undergo surveillance colonoscopy.\n* The patients with ulcerative colitis for ulcerative colitis group.\n* The patients without ulcerative colitis for control group.\n* 18-80 years.\n\nExclusion Criteria:\n\n* Using antibiotics, glucocorticoid and immunosuppressants wintin one month.\n* There are contraindications for enteroscopy and biopsy.\n* There are other intestinal diseases.\n* Pregnancy or breast-feeding women.\n* Patients with serious lung disease and mental illness.'}, 'identificationModule': {'nctId': 'NCT03151850', 'briefTitle': 'The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Different Degree of Inflammation of Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'The Diversity of the Fungal and Bacterial in Colon Mucosa of Patients With Ulcerative Colitis Associated Different Clinical Classification', 'orgStudyIdInfo': {'id': '2015SDU-QILU-G004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ulcerative colitis', 'description': 'We analysed the diversity of the fungal and bacterial in patients with Ulcerative Colitis (UC). We take 2 pieces of biopsies in the sigmoid colon mucosa inflammation area during the colonoscopy and then perform gene sequencing.', 'interventionNames': ['Other: ulcerative colitis']}, {'label': 'Control', 'description': 'Analysing the diversity of the fungal and bacterial in patients without ulcerative colitis. We take 2 pieces of biopsies in the sigmoid colon mucosa during the colonoscopy and then perform gene sequencing.', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'ulcerative colitis', 'type': 'OTHER', 'otherNames': ['Patients With ulcerative colitis'], 'description': 'We take 2 pieces of biopsies in the sigmoid colon mucosa inflammation area during the colonoscopy and then perform gene sequencing.', 'armGroupLabels': ['ulcerative colitis']}, {'name': 'Control', 'type': 'OTHER', 'otherNames': ['Patients Without ulcerative colitis'], 'description': 'We take 2 pieces of biopsies in the sigmoid colon mucosa during the colonoscopy and then perform gene sequencing.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiuli Zuo, PhD', 'role': 'CONTACT', 'email': 'zuoxiuli@sina.com', 'phone': '15588818685', 'phoneExt': '053188369277'}, {'name': 'Lidong Xu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Xiuli Zuo, PhD', 'role': 'CONTACT', 'email': 'zuoxiuli@sina.com', 'phone': '15588818685', 'phoneExt': '053188369277'}], 'overallOfficials': [{'name': 'Xiuli Zuo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital of Shandong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiuli Zuo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy director of the physician', 'investigatorFullName': 'Xiuli Zuo', 'investigatorAffiliation': 'Shandong University'}}}}