Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-05 @ 7:02 PM
Study NCT ID:
NCT02008604
Status:
COMPLETED
Last Update Posted:
2018-11-29
First Post:
2013-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Stroke on the Composition of Intestinal Microbiota
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool samples, Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2013-11-15', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composition of intestinal microbiome', 'timeFrame': 'change between day 1, day 4, day 7, day 14 after stroke', 'description': 'The composition of the intestinal metagenome / microbiome will be determined by analyzing the 16S rRNA by 454 Pyrosequencing.'}], 'secondaryOutcomes': [{'measure': 'test of correlation between most changed group of bacteria with changes in immunological parameters (HLA-DR)', 'timeFrame': 'days 1, 4, 7 after stroke', 'description': 'Analysis of correlation between changes in microbiome (most changed group of bacteria, e.g. lactobacilli) with changes in immunological parameters (e.g. HLA-DR, IL-6, IL-10, CD4-lymphocytes from blood samples).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ischemia', 'stroke', 'transient ischemic attack (TIA)', 'microbiome', 'microbiota', 'gut'], 'conditions': ['Stroke', 'Transient Ischemic Attack (TIA)']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to verify the hypothesis that the microbial colonisation of the gut is changed in patients after stroke and that the gut microbiome of severely affected stroke patients differs from that of patients with only a short disruption of blood circulation in the brain (transient ischemic attack, TIA). For this, the composition of gut microbiota in stool samples will be analyzed by 454 pyrosequencing. Further, the correlation of stroke-associated changes in the microbiome with immunological parameters will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients at the rescue center, the Stroke Unit and the neurological intensive care unit of the Charité University hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 18 and older\n* ischemic cerebral infarction within the last 40 hours, anterior circulation infarct (ACA, MCA) and/or posterior circulation infarct (PCA, BA) of any severity\n* patient consent or consent by a legal representative\n* NIHSS \\> or =9 (stroke patients)\n* NIHSS \\< 1 (for TIA patients)\n\nExclusion Criteria:\n\n* intracranial hemorrhage\n* preexisting dysphagia\n* signs of infection upon admission (clinical/paraclinical)\n* existing antibiotic therapy upon admission or within the last 2 weeks before admission\n* mechanical ventilation upon admission\n* participation in an interventional therapy study'}, 'identificationModule': {'nctId': 'NCT02008604', 'acronym': 'GUTSTROKE', 'briefTitle': 'Influence of Stroke on the Composition of Intestinal Microbiota', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Influence of Stroke on the Composition of Intestinal Microbiota (GUTSTROKE)', 'orgStudyIdInfo': {'id': 'GUTSTROKE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke patients'}, {'label': 'TIA patients', 'description': 'patients with a transient ischemic attack (control group)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Andreas Meisel, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prof. Dr. Ulrich Dirnagl, Experimental Neurology, Charité Berlin, Germany', 'class': 'UNKNOWN'}, {'name': 'Dr. Christian Meisel, Medical Immunology, Charité Berlin, Germany', 'class': 'UNKNOWN'}, {'name': 'PD Dr. Andreas Nitsche, Robert-Koch-Institut, Berlin, Germany', 'class': 'UNKNOWN'}, {'name': 'NeuroCure Clinical Research Center, Charite, Berlin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Andreas Meisel', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}