Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
220 participants
INTERVENTIONAL
2019-12-15
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Probiotic group
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.
Bifidobacterium triple live capsule
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.
Placebo group
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.
Placebos
Placebos were administrated as same as the bifidobacterium live capsule
Interventions
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Bifidobacterium triple live capsule
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.
Placebos
Placebos were administrated as same as the bifidobacterium live capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. . Can communicate normally
3. . Selective knee ankle, hip replacement or lumbar open reduction and internal fixation under general anesthesia
4. . ASA graded at I-II level
5. . Patient or family informed consent
Exclusion Criteria
2. .MMSE check of less than 24 points.
3. . History of neurological and psychological disorders including AD, stroke, psychosis
4. . Serious hearing or visual impairment
5. . Preoperative systolic blood pressure \>190mmhg, or diastolic blood pressure \>100mmhg
6. . The patient or family refuses
65 Years
80 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Responsible Party
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Principal Investigators
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su diansan
Role: STUDY_CHAIR
RenJi Hospital
Locations
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Renji Hospital
Shanghai, Shanghai Municipality, China
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai Municipality, China
Jin Cheng people's hospital
Jincheng, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Jinping Wang
Role: primary
References
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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.
Other Identifiers
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PAPOCD
Identifier Type: -
Identifier Source: org_study_id
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