Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-02-27 @ 4:05 PM
Study NCT ID:
NCT02699060
Status:
COMPLETED
Last Update Posted:
2022-02-18
First Post:
2016-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Experimental Study to Determine the Effects of Human Refluxate on Macrophage Phenotype and Its Correlation With GERD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'motility_2013@mail.ru', 'phone': '+79252667987', 'title': 'MD, PhD Ivashkin Vladimir Trofimovich', 'organization': 'IMSechenovMMA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '32 weeks', 'description': "We haven't adverse events because we not used drugs in our study.", 'eventGroups': [{'id': 'EG000', 'title': 'NERD Patients', 'description': 'Patients have the typical reflux syndrome without esophageal injury.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'EE Patients', 'description': 'Patients have erosion(s) or ulcer(s) in esophagus.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BE Patients', 'description': 'Patients have specialized esophageal intestinal metaplasia.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Number of Reflux in GERD Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'NERD Patients', 'description': 'Patients with heartburn were found to exhibit inflammatory esophageal mucosa during endoscopy'}, {'id': 'OG001', 'title': 'EE Patients', 'description': 'Patients with erosions or ulcers in esophagus by endoscopy'}, {'id': 'OG002', 'title': 'BE Patients', 'description': 'Patients with intestinal metaplasia in esophagus'}], 'classes': [{'title': 'The acid reflux episodes', 'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '79.0'}, {'value': '42.8', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '111.0'}, {'value': '81.0', 'groupId': 'OG002', 'lowerLimit': '12.0', 'upperLimit': '211.0'}]}]}, {'title': 'The weakly acid reflux episodes', 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000', 'lowerLimit': '28.8', 'upperLimit': '99.0'}, {'value': '34.4', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '100.0'}, {'value': '31.8', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '100.0'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.76', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.80', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 4', 'description': 'We analyzed the number of acid and weakly acid reflux episodes in GERD patients', 'unitOfMeasure': 'episodes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GERD', 'description': 'NERD patients, EE patients and BE patients'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Non Erosive Reflux Disease', 'description': 'Participants not received drugs'}, {'id': 'BG001', 'title': 'Erosive Esophagitis', 'description': 'Participants not received drugs'}, {'id': 'BG002', 'title': "Barrett's Esophagus", 'description': 'Participants not received drugs'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '45.74', 'spread': '2.23', 'groupId': 'BG000'}, {'value': '45.0', 'spread': '3.24', 'groupId': 'BG001'}, {'value': '47.22', 'spread': '2.95', 'groupId': 'BG002'}, {'value': '46.8', 'spread': '12.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'years', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Expression levels macrophage CD markers from GERD patients', 'classes': [{'title': 'CD25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '34.6', 'spread': '15.9', 'groupId': 'BG000'}, {'value': '34.2', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '40.0', 'spread': '14.4', 'groupId': 'BG002'}, {'value': '36.9', 'spread': '15.2', 'groupId': 'BG003'}]}]}, {'title': 'CD80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '23.0', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '23.5', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '24.4', 'spread': '11.5', 'groupId': 'BG002'}, {'value': '23.4', 'spread': '11.8', 'groupId': 'BG003'}]}]}, {'title': 'CD163', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '16.6', 'spread': '15.9', 'groupId': 'BG000'}, {'value': '18.0', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '14.3', 'spread': '8.1', 'groupId': 'BG002'}, {'value': '16.3', 'spread': '9.1', 'groupId': 'BG003'}]}]}, {'title': 'CD206', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '11.9', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '9.6', 'spread': '7.7', 'groupId': 'BG002'}, {'value': '10.6', 'spread': '7.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/l', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-10-12', 'size': 554876, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-11T13:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-17', 'studyFirstSubmitDate': '2016-02-12', 'resultsFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2016-03-03', 'lastUpdatePostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-17', 'studyFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Number of Reflux in GERD Patients', 'timeFrame': 'Day 4', 'description': 'We analyzed the number of acid and weakly acid reflux episodes in GERD patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GERD', "Barrett's esophagus", 'macrophage', 'FSSG questionnaire'], 'conditions': ['Gastroesophageal Reflux Disease (GERD)']}, 'referencesModule': {'references': [{'pmid': '21479676', 'type': 'BACKGROUND', 'citation': "Zhong YQ, Lin Y, Xu Z. Expression of IFN-gamma and IL-4 in the esophageal mucosa of patients with reflux esophagitis and Barrett's esophagus and their relationship with endoscopic and histologic grading. Dig Dis Sci. 2011 Oct;56(10):2865-70. doi: 10.1007/s10620-011-1696-9. Epub 2011 Apr 9."}, {'pmid': '21590343', 'type': 'BACKGROUND', 'citation': "Kohata Y, Fujiwara Y, Machida H, Okazaki H, Yamagami H, Tanigawa T, Watanabe K, Watanabe T, Tominaga K, Wei M, Wanibuchi H, Arakawa T. Role of Th-2 cytokines in the development of Barrett's esophagus in rats. J Gastroenterol. 2011 Jul;46(7):883-93. doi: 10.1007/s00535-011-0405-y. Epub 2011 May 18."}, {'pmid': '15842572', 'type': 'BACKGROUND', 'citation': 'Gough MD, Ackroyd R, Majeed AW, Bird NC. Prediction of malignant potential in reflux disease: are cytokine polymorphisms important? Am J Gastroenterol. 2005 May;100(5):1012-8. doi: 10.1111/j.1572-0241.2005.40904.x.'}, {'pmid': '11889061', 'type': 'BACKGROUND', 'citation': 'Fitzgerald RC, Onwuegbusi BA, Bajaj-Elliott M, Saeed IT, Burnham WR, Farthing MJ. Diversity in the oesophageal phenotypic response to gastro-oesophageal reflux: immunological determinants. Gut. 2002 Apr;50(4):451-9. doi: 10.1136/gut.50.4.451.'}], 'seeAlsoLinks': [{'url': 'http://www.mma.ru/en/', 'label': 'I.M.Sechenov First Moscow State Medical University website'}]}, 'descriptionModule': {'briefSummary': 'This study is proposed to evaluate the role of motoric dysfunctions and type of refluxate in GERD patients, analyzed the blood monocyte/macrophage phenotypes of gastroesophageal reflux diseases (GERD) patients.', 'detailedDescription': 'Patients with non-erosive gastroesophageal reflux disease (NERD), erosive esophagitis (EE) and Barrett esophagus (BE) were enrolled. We investigated blood monocyte/macrophage phenotype in patients with different forms of GERD. We analysed of macrophages phenotype by CD25, CD80, CD163, CD206 expression for M2 macrophages. All patients underwent upper gastrointestinal endoscopy with esophagus biopsy. GERD patients underwent esophageal high-resolution manometry (HRM) with a 22-channel water-perfused catheter and Solar GI system (Medical Measurements Systems, Enschede, the Netherlands) and 24-hour impedance and pH monitoring using the Ohmega Ambulatory Impedance pH Recorder (Medical Measurements Systems).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical (patients) part\n\n1. Signed informed consent\n2. Gender: Male or Female\n3. Age: 18-65 years of age\n\n3\\. Clinically and/or endoscopically confirmed diagnosis of GERD\n\nExclusion Criteria:\n\nClinical: (patient)\n\n1. Current treatment with proton pump inhibitors and/or histamine-2 receptor antagonists. These treatments should have been stopped at least 1 week prior to study inclusion.\n2. Female patients who are pregnant, planning to become pregnant or lactating\n3. Any acute diseases or conditions, exacerbations of concomitant chronic diseases (including but not limited to inflammatory bowel disease (IBD), ulcer disease etc.) at study start/inclusion and/or which are not resolved 14 days prior to study-enrolment.\n4. Participation in a clinical trial in the past 3 months\n5. Any condition which, in the opinion of investigator, makes the patient unsuitable for participation in the study'}, 'identificationModule': {'nctId': 'NCT02699060', 'briefTitle': 'Experimental Study to Determine the Effects of Human Refluxate on Macrophage Phenotype and Its Correlation With GERD', 'organization': {'class': 'OTHER', 'fullName': 'I.M. Sechenov First Moscow State Medical University'}, 'officialTitle': 'Experimental Study to Determine the Effects of Human Refluxate (Biliary, Gastric, Duodenogastric) on Macrophage Phenotype and Its Correlation With Different Forms of GERD: Motility Talent Group Study', 'orgStudyIdInfo': {'id': 'EPIDKO19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NERD patients', 'description': 'Patients have typical reflux syndrome without esophageal injury.', 'interventionNames': ['Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate', 'Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring']}, {'type': 'EXPERIMENTAL', 'label': 'EE patients', 'description': 'Patients have erosion(s) or ulcer(s) in esophagus.', 'interventionNames': ['Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate', 'Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring']}, {'type': 'EXPERIMENTAL', 'label': 'BE patients', 'description': 'Patients have esophageal specialized intestinal metaplasia.', 'interventionNames': ['Procedure: Upper gastrointestinal endoscopy with biopsy and collection of refluxate', 'Procedure: Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring']}], 'interventions': [{'name': 'Upper gastrointestinal endoscopy with biopsy and collection of refluxate', 'type': 'PROCEDURE', 'otherNames': ['EGD (esophagogastroduodenoscopy) with esophagus biopsy'], 'description': 'we analyzed esophageal mucosa, expression of inflammatory changes, location, size, number of mucosal defects, as well as the appearance of the gastric and duodenal mucosa.', 'armGroupLabels': ['BE patients', 'EE patients', 'NERD patients']}, {'name': 'Esophageal high-resolution manometry and 24-h esophageal pH-impedance monitoring', 'type': 'PROCEDURE', 'otherNames': ['HRM and 24-h esophageal pH monitoring'], 'description': 'we analyzed following HRM parameters: the distal contractile integral (DCI), the lower esophageal sphincter resting pressure (LES RP) and standard measuring parameters were be collected: percentage of total time when pH was \\<4, longest reflux event, number of reflux events longer than 5 minutes, and number of reflux episodes in 24 hours.', 'armGroupLabels': ['BE patients', 'EE patients', 'NERD patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'I.M.Sechenov First Moscow State Medical University', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '127473', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow State University of Medicine and Dentistry named after A.I. Evdokimov', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Vladimir Ivashkin, MD,PhD,Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'I.M. Sechenov First Moscow State Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ivashkin Vladimir Trofimovich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, professor, head of department of propedeutics of internal diseases, director of clinic of propedeutics of internal diseases', 'investigatorFullName': 'Ivashkin Vladimir Trofimovich', 'investigatorAffiliation': 'I.M. Sechenov First Moscow State Medical University'}}}}