Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 11:03 AM
Study NCT ID:
NCT04017403
Status:
UNKNOWN
Last Update Posted:
2022-05-02
First Post:
2019-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Probiotics Attenuate Postoperative Cognition Decline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D005265', 'term': 'Femoral Neck Fractures'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-26', 'studyFirstSubmitDate': '2019-07-09', 'studyFirstSubmitQcDate': '2019-07-10', 'lastUpdatePostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of POCD 7days after surgery', 'timeFrame': 'The seventh day after surgery'}], 'secondaryOutcomes': [{'measure': 'Incidence of POCD 1 month after operation', 'timeFrame': 'One month after surgery'}, {'measure': 'Incidence of POD 7 days after surgery', 'timeFrame': 'One day after surgery to the seventh day after surgery', 'description': 'Use the CAM scale to assess whether a patient has postoperative delirium'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative cognitive dysfunction', 'postopeartive delirium', 'Probiotics'], 'conditions': ['Necrosis of Femoral Head', 'Knee Osteoarthritis', 'Fracture of Neck of Femur', 'Lumbar Disc Herniation']}, 'referencesModule': {'references': [{'pmid': '36841790', 'type': 'DERIVED', 'citation': 'Zhang X, Chen Y, Tang Y, Zhang Y, Zhang X, Su D. Efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: a study protocol for a multicenter, randomized controlled trial. Trials. 2023 Feb 25;24(1):146. doi: 10.1186/s13063-023-07167-6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate whether perioperative probiotics can reduce the incidence of postoperative cognitive dysfunction and postoperative delirium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. . Age is greater than or equal to 65 years old\n2. . Can communicate normally\n3. . Selective knee ankle, hip replacement or lumbar open reduction and internal fixation under general anesthesia\n4. . ASA graded at I-II level\n5. . Patient or family informed consent\n\nExclusion Criteria:\n\n1. . Have a brain disease, or have a history of brain disease\n2. .MMSE check of less than 24 points.\n3. . History of neurological and psychological disorders including AD, stroke, psychosis\n4. . Serious hearing or visual impairment\n5. . Preoperative systolic blood pressure \\>190mmhg, or diastolic blood pressure \\>100mmhg\n6. . The patient or family refuses'}, 'identificationModule': {'nctId': 'NCT04017403', 'briefTitle': 'Probiotics Attenuate Postoperative Cognition Decline', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Probiotics Oral Administration Attenuate Postoperative Cognition Decline in Elderly Orthopedic Patients', 'orgStudyIdInfo': {'id': 'PAPOCD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic group', 'description': 'The probiotic group was treated with Bifidobacterium tripleis,one day before surgery to the sixth day after surgerythe drug is taken orally, 4 capsules at a time, 2 times a day.', 'interventionNames': ['Drug: Bifidobacterium triple live capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'The control group was given the same package of placebo,one day before surgery to the sixth day after surgery. The drug is taken orally, 4 capsules at a time, 2 times a day.', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Bifidobacterium triple live capsule', 'type': 'DRUG', 'otherNames': ['Peifei Kang Capsule'], 'description': 'Bifidobacterium triple live capsules, indications for acute and chronic diarrhea and constipation caused by intestinal flora imbalance, can also be used for the treatment of mild to moderate acute diarrhea, chronic diarrhea and indigestion, bloating, and adjuvant treatment of intestinal flora Endotoxemia caused by disorders.', 'armGroupLabels': ['Probiotic group']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebos were administrated as same as the bifidobacterium live capsule', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'diansan su, Dr.', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+862168383702'}], 'facility': 'Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoxue Hu', 'role': 'CONTACT', 'email': 'ykxiaoxue@126.com'}], 'facility': 'Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Jincheng', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinping Wang', 'role': 'CONTACT'}], 'facility': "Jin Cheng people's hospital", 'geoPoint': {'lat': 35.50222, 'lon': 112.83278}}], 'centralContacts': [{'name': 'tang ying, Bachelor', 'role': 'CONTACT', 'email': '421941497@qq.com', 'phone': '13918859887', 'phoneExt': '18616514088'}, {'name': 'su diansan, Doctor', 'role': 'CONTACT', 'email': '184872238@qq.com', 'phone': '18616514088', 'phoneExt': '18616514088'}], 'overallOfficials': [{'name': 'su diansan', 'role': 'STUDY_CHAIR', 'affiliation': 'RenJi Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}