NCT04017403

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

December 15, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 2, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

July 9, 2019

Last Update Submit

April 26, 2022

Conditions

Necrosis of Femoral HeadKnee OsteoarthritisFracture of Neck of FemurLumbar Disc Herniation

Keywords

postoperative cognitive dysfunctionpostopeartive deliriumProbiotics

Outcome Measures

Primary Outcomes (1)

  • Incidence of POCD 7days after surgery

    The seventh day after surgery

Secondary Outcomes (2)

  • Incidence of POCD 1 month after operation

    One month after surgery

  • Incidence of POD 7 days after surgery

    One day after surgery to the seventh day after surgery

Study Arms (2)

Probiotic group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Bifidobacterium triple live capsuleDRUG

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.

Also known as: Peifei Kang Capsule
Probiotic group
PlacebosDRUG

Placebos were administrated as same as the bifidobacterium live capsule

Also known as: Placebo
Placebo group

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age is greater than or equal to 65 years old
  • Can communicate normally
  • Selective knee ankle, hip replacement or lumbar open reduction and internal fixation under general anesthesia
  • ASA graded at I-II level
  • Patient or family informed consent

You may not qualify if:

  • Have a brain disease, or have a history of brain disease
  • MMSE check of less than 24 points.
  • History of neurological and psychological disorders including AD, stroke, psychosis
  • Serious hearing or visual impairment
  • Preoperative systolic blood pressure \>190mmhg, or diastolic blood pressure \>100mmhg
  • The patient or family refuses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Jin Cheng people's hospital

Jincheng, Shanxi, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36841790DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeFemoral Neck FracturesIntervertebral Disc DisplacementPostoperative Cognitive Complications

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesHip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesSpinal DiseasesBone DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • su diansan

    RenJi Hospital

    STUDY CHAIR

Central Study Contacts

tang ying, Bachelor

CONTACT

13918859887421941497@qq.com

su diansan, Doctor

CONTACT

18616514088184872238@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2019

First Posted

July 12, 2019

Study Start

December 15, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 2, 2022

Record last verified: 2022-04

Locations

CN(3)