Probiotics Attenuate Postoperative Cognition Decline

Probiotics Oral Administration Attenuate Postoperative Cognition Decline in Elderly Orthopedic Patients

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

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Lumbar Disc Herniation; Necrosis of Femoral Head; Fracture of Neck of Femur
• Intervention / Treatment: Drug: Bifidobacterium triple live capsule; Drug: Placebos

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: tang ying, Bachelor; Phone Number: 18616514088 13918859887; Email: 421941497@qq.com
• Study Contact Backup: Name: su diansan, Doctor; Phone Number: 18616514088 18616514088; Email: 184872238@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • RenJi Hospital
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
      • Contact: Xiaoxue Hu; Email: ykxiaoxue@126.com
  • Shanxi
    • Jincheng, Shanxi, China
      • Recruiting
      • Jin Cheng people's hospital
      • Contact: Jinping Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years to 78 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Peifei Kang Capsule
Placebo Comparator: 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.	Drug: Placebos; Placebos were administrated as same as the bifidobacterium live capsule; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of POCD 7days after surgery	The seventh day after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Chair: su diansan, RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Probiotics; postoperative cognitive dysfunction; postopeartive delirium
• Additional Relevant MeSH Terms: Pathologic Processes; Fractures, Bone; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Femoral Fractures; Hip Injuries; Osteoarthritis; Hip Fractures; Hernia; Osteoarthritis, Knee; Intervertebral Disc Displacement; Necrosis; Femoral Neck Fractures
• Other Study ID Numbers: PAPOCD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No