Clinical Trials Logo
  1. Home
  2. Knee Osteoarthritis
  3. NCT04017403
  4. Details
NCT04017403 Clinical Trial

Probiotics Attenuate Postoperative Cognition Decline

Knee Osteoarthritis Clinical Trial

Official title:
Probiotics Oral Administration Attenuate Postoperative Cognition Decline in Elderly Orthopedic Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04017403
Other study ID # PAPOCD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2019
Est. completion date December 31, 2023

Study information
Verified date April 2022
Source RenJi Hospital
Contact tang ying, Bachelor
Phone 13918859887
Email 421941497@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 220
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
• Placebos
Placebos were administrated as same as the bifidobacterium live capsule

Locations
Country Name City State
China Jin Cheng people's hospital Jincheng Shanxi
China Renji Hospital Shanghai Shanghai
China Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of POCD 7days after surgery The seventh day after surgery
Secondary Incidence of POCD 1 month after operation One month after surgery
Secondary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04651673 - Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Completed NCT05677399 - Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise. N/A
Active, not recruiting NCT04043819 - Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis Phase 1
Recruiting NCT06000410 - A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee Phase 3
Completed NCT05014542 - Needling Techniques for Knee Osteoarthritis N/A
Recruiting NCT05892133 - Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty N/A
Recruiting NCT05528965 - Parallel Versus Perpendicular Technique for Genicular Radiofrequency N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Active, not recruiting NCT02003976 - A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone N/A
Active, not recruiting NCT04017533 - Stability of Uncemented Medially Stabilized TKA N/A
Completed NCT04779164 - The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis N/A
Recruiting NCT04006314 - Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis N/A
Recruiting NCT05423587 - Genicular Artery Embolisation for Knee Osteoarthritis II N/A
Enrolling by invitation NCT04145401 - Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Active, not recruiting NCT03781843 - Effects of Genicular Nerve Block in Knee Osteoarthritis N/A
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05324163 - Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis Phase 3
Completed NCT05529914 - Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis N/A
Recruiting NCT05693493 - Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA? N/A
Not yet recruiting NCT05510648 - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis N/A