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Probiotics Attenuate Postoperative Cognition Decline

Probiotics Oral Administration Attenuate Postoperative Cognition Decline in Elderly Orthopedic Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04017403
Enrollment
220
Registered
2019-07-12
Start date
2019-12-15
Completion date
2023-12-31
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture of Neck of Femur, Knee Osteoarthritis, Lumbar Disc Herniation, Necrosis of Femoral Head

Keywords

postoperative cognitive dysfunction, postopeartive delirium, Probiotics

Brief summary

The aim of this study was to evaluate whether perioperative probiotics can reduce the incidence of postoperative cognitive dysfunction and postoperative delirium.

Interventions

DRUGBifidobacterium 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.

DRUGPlacebos

Placebos were administrated as same as the bifidobacterium live capsule

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. . Age is greater than or equal to 65 years old 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

1. . Have a brain disease, or have a history of brain disease 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

Design outcomes

Primary

MeasureTime frame
Incidence of POCD 7days after surgeryThe seventh day after surgery

Secondary

MeasureTime frameDescription
Incidence of POCD 1 month after operationOne month after surgery
Incidence of POD 7 days after surgeryOne day after surgery to the seventh day after surgeryUse the CAM scale to assess whether a patient has postoperative delirium

Countries

China

Contacts

Primary Contacttang ying, Bachelor
421941497@qq.com13918859887
Backup Contactsu diansan, Doctor
184872238@qq.com18616514088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026