Probiotics Attenuate Postoperative Cognition Decline

Not Applicable

• Conditions: Necrosis of Femoral Head; Knee Osteoarthritis; Lumbar Disc Herniation; Fracture of Neck of Femur
• Interventions: Drug: Bifidobacterium triple live capsule; Drug: Placebos

• Registration Number: NCT04017403
• Lead Sponsor: RenJi Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-12
• Study Start: 2019-12-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-05-02
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	Bifidobacterium triple live capsule	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.
Placebo group	Placebos	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.

Primary Outcome Measures

Name	Time	Method
Incidence of POCD 7days after surgery	The seventh day after surgery

Secondary Outcome Measures

Name	Time	Method
Incidence of POD 7 days after surgery	One day after surgery to the seventh day after surgery	Use the CAM scale to assess whether a patient has postoperative delirium
Incidence of POCD 1 month after operation	One month after surgery

Trial Locations

Locations (3)

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine; 🇨🇳 Shanghai, Shanghai, China

Jin Cheng people's hospital; 🇨🇳 Jincheng, Shanxi, China

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China