Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT05414227
Status:
UNKNOWN
Last Update Posted:
2022-06-10
First Post:
2022-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Association of Gut Microbes and Their Metabolites With Post-stroke Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Faecal samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-08', 'studyFirstSubmitDate': '2022-06-08', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score', 'timeFrame': '3 months', 'description': 'Mild depression（HAMD-17 Score≥7，\\<17）, moderate depression（HAMD-17 Score≥17，\\<24）, major depression（HAMD-17 Score≥24）'}, {'measure': 'The PSD Assessed by Hamilton Rating Scale for Depression (HAMD-17) Score', 'timeFrame': '6 months', 'description': 'Mild depression（HAMD-17 Score≥7，\\<17）, moderate depression（HAMD-17 Score≥17，\\<24）, major depression（HAMD-17 Score≥24）'}, {'measure': 'The PSF Assessed by Fatigue Severity Scale（FSS）', 'timeFrame': '3 months', 'description': 'Fatigue（≥36）'}, {'measure': 'The PSF Assessed by Fatigue Severity Scale（FSS）', 'timeFrame': '6 months', 'description': 'Fatigue（FSS Score ≥36）'}, {'measure': 'Functional Independence Assessed by Modified Rankin Scale (mRS）score', 'timeFrame': '3 months', 'description': 'MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score\\>2), and death (mRS score = 6)'}, {'measure': 'Functional Independence Assessed by Modified Rankin Scale (mRS）score', 'timeFrame': '6 months', 'description': 'MRS score range from 0 to 6. Favourable outcome (mRS score≤2), worse outcome (mRS score\\>2), and death (mRS score = 6)'}], 'secondaryOutcomes': [{'measure': 'Gut microbial composition and diversity', 'timeFrame': 'First stool after admission', 'description': 'Results of fecal bacteria by 16s RNA sequencing'}, {'measure': 'Serum metabolites of gut microbiota', 'timeFrame': '7 days within stroke onset', 'description': 'Serum metabolites of gut microbiota from stool, detected by liquid chromatography-mass spectrometry (LC-MS) combined technique'}, {'measure': 'Serum inflammatory cytokines', 'timeFrame': '7 days within stroke onset', 'description': 'Inflammatory cytokines in blood，detected by flow cytometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gut flora', 'Acute Ischemic Stroke', 'Prognosis'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'In this study, the clinical data of patients with AIS were collected, 16s RNA was used to detect the composition and diversity of intestinal flora, and flow cytometry and mass spectrometry were used to detect intestinal flora-related metabolites in plasma，to explore the influence of gut microbiota and its metabolites on stroke prognosis.', 'detailedDescription': 'In recent years, more and more studies have been conducted on the gut-brain axis, and gut microbes can affect the brain by regulating immune responses, metabolites, and neurotransmitters. The composition of gut microbiota may affect stroke prognosis, including focal neurological deficits, cognitive impairment, anxiety and depression, and fatigue. In this study, 16s RNA was used to detect the composition and diversity of intestinal flora, and flow cytometry and mass spectrometry were used to detect intestinal flora-related metabolites in plasma. The clinical data of patients were collected, including age, gender, and medical history, NIHSS, mRS, MMSE, Patient Health Questionnaire-9（PHQ9）, Social Support Rating Scale（SSRS）, laboratory and radiology results. The neurological recovery of the patients was assessed after 3 and 6 months, and the presence or absence of post-stroke depression（PSD） and post-stroke fatigue（PSF） was assessed by the Hamilton Depression Scale, the Fatigue Severity Scale（FSS） and the Multidimensional Fatigue Scale（MFS）. To evaluate the relationship between gut microbiota and its metabolites and stroke prognosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ischemic stroke within 7 days of onset', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who suffered from acute ischemic stroke\n2. Within 7 days of the onset\n3. Signing the informed consent, willing and able to attend all study visits\n\nExclusion Criteria:\n\n1. Severe aphasia，dysarthria, hearing loss，cognitive and consciousness impairment and unable to cooperate\n2. Previous diagnosis of depression or other mental disorder or who had recently accepted antidepressants or antipsychotics\n3. Gastrointestinal disease, and pregnant or lactating women\n4. Serious systemic diseases including malignant tumors\n5. Any antibiotics, probiotics or prebiotic treatment within 1 months'}, 'identificationModule': {'nctId': 'NCT05414227', 'briefTitle': 'The Association of Gut Microbes and Their Metabolites With Post-stroke Depression', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Xuzhou Medical University'}, 'officialTitle': 'Research on the Association of Gut Microbes and Their Metabolites With Post-stroke Depression', 'orgStudyIdInfo': {'id': 'XYFY2022-KL204'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PSD', 'description': 'Depressed as assessed by the Hamilton Depression Scale 3 months after stroke'}, {'label': 'Non PSD', 'description': 'Nondepressed as assessed by the Hamilton Depression Scale 3 months after stroke'}]}, 'contactsLocationsModule': {'locations': [{'zip': '221002', 'city': 'Xuzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chen Renguo, Master', 'role': 'CONTACT'}], 'facility': 'The Affiliated Hospital of Xuzhou Medical University', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'centralContacts': [{'name': 'Zhang Wei, Master', 'role': 'CONTACT', 'email': 'neurodoc0708@126.com', 'phone': '15162113531'}, {'name': 'Hua Fang, PhD', 'role': 'CONTACT', 'email': 'huafang@xzmc.edu.cn', 'phone': '15252144898'}], 'overallOfficials': [{'name': 'Chen Renguo, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'The Affiliated Hospital of Xuzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Xuzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}