Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2026-01-04 @ 8:45 AM
Study NCT ID:
NCT03259659
Status:
TERMINATED
Last Update Posted:
2020-07-31
First Post:
2017-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064307', 'term': 'Microbiota'}], 'ancestors': [{'id': 'D008827', 'term': 'Microbiological Phenomena'}, {'id': 'D058448', 'term': 'Biota'}, {'id': 'D044822', 'term': 'Biodiversity'}, {'id': 'D017753', 'term': 'Ecosystem'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood sample for inflammatory cytokines, fecal sample for microbiota'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Principal Investigator was leaving the institution.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-08-21', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'symptoms characteristics in ulcerative colitis patients', 'timeFrame': '1 day', 'description': 'ulcerative colitis disease activity index will be assessed using the Mayo scoring system, which includes stool frequency, rectal bleeding, mucosal appearance at endoscopy and physician rating of disease activity. The patient will get a score from 0 to 20, with higher score indicating more severe disease.'}], 'secondaryOutcomes': [{'measure': 'autonomic profile characteristics in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'heart rate variability indicating sympathetic and parasympathetic activity'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Granulocyte-colony stimulating factor (G-CSF)'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Eotaxin'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Granulocyte-macrophage colony-stimulating factor (GM-CSF)'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, interleukin (IL) -1α'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Leptin'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Macrophage Inflammatory Proteins (MIP) -1α'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, interleukin (IL) -4'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, interleukin (IL) -1β'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, interleukin (IL) -2'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, interleukin (IL) -6'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Epidermal growth factor (EGF)'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, interleukin (IL) -13'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, interleukin (IL) -10'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, interleukin (IL) -12p70'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Interferon gamma (IFNγ)'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, interleukin (IL) -5'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, interleukin (IL) -17A'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, interleukin (IL) -18'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Monocyte Chemoattractant Protein-1 (MCP-1)'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Interferon - induced protein 10 (IP-10),'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, growth regulated oncogene (GRO)/Keratinocyte chemoattractant KC/cytokine-induced neutrophil chemoattractant (CINC)-1'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Vascular endothelial growth factor (VEGF)'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Fractalkine'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Lipopolysaccharide-induced CXC chemokine (LIX)'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Macrophage Inflammatory Proteins (MIP) -2'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, Tumor necrosis factor (TNF) α'}, {'measure': 'inflammatory cytokine profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'blood sample, RANTES (Regulated on Activation, Normal T Cell Expressed and Secreted)'}, {'measure': 'microbiota profile in ulcerative colitis patients and healthy controls', 'timeFrame': '1 day', 'description': 'fecal sample microbiota analysis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': '1. To prove that patients with ulcerative proctitis and proctosigmoiditis have impaired autonomic functions, i.e. increased sympathetic activity and/or reduced vagal tone.\n2. To demonstrate inflammatory cytokine imbalance, i.e., increased pro-inflammatory cytokines. Presence of these abnormalities would make patients with ulcerative proctitis and proctosigmoiditis good candidates for future sacral nerve stimulation therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'irritable bowel disease patients and healthy controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No any systemic diseases;\n* no proctitis or proctosigmoiditis;\n* no history of gastrointestinal surgery;\n* no symptoms of diarrhea or fecal urgency during the past 2 weeks;\n* not taking any medications except contraceptives during the past 2 weeks;\n* age 18-65.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT03259659', 'briefTitle': 'Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Autonomic and Cytokines Profiles of Patients With Ulcerative Proctitis', 'orgStudyIdInfo': {'id': 'IRB00095405'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'irritable bowel disease patient', 'description': 'Patients with ulcerative proctitis and proctosigmoiditis who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index.', 'interventionNames': ['Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index']}, {'label': 'healthy control', 'description': 'Healthy participates who meet the inclusion criteria, they will have ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index.', 'interventionNames': ['Other: ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index']}], 'interventions': [{'name': 'ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index', 'type': 'OTHER', 'description': 'In this study, an electrocardiogram signal will be recorded for 30 min in the fasting state, and blood samples for inflammatory cytokines analysis (7 ml) will be taken at the end of the ECG recording; fecal samples will be taken on the experimental day before the study. In addition, ulcerative colitis disease activity index will be assessed using the Mayo scoring system.', 'armGroupLabels': ['healthy control', 'irritable bowel disease patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Jiande Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}