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Status unknownNCT04017403Updated May 2, 2022

Probiotics Attenuate Postoperative Cognition Decline

An interventional study of Bifidobacterium triple live capsule and Placebos in Necrosis of Femoral Head, Knee Osteoarthritis and Fracture of Neck of Femur, sponsored by RenJi Hospital. Status unknown at 3 sites in China. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-05-02.

Sponsored by RenJi Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
65 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

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

Keywords

  • postoperative cognitive dysfunction
  • postopeartive delirium
  • Probiotics
03

In context

Intervertebral Disc Displacement

477 studies on the registry are indexed under Intervertebral Disc Displacement; 103 are open to participants now.

This study's planned enrollment of 220 is above the median of 63 across 344 interventional studies indexed under Intervertebral Disc Displacement.

Browse Intervertebral Disc Displacement studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
220 participants (estimated)

Study arms

  • 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

  • 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

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.

    Also known as: Peifei Kang Capsule

  • DrugPlacebos

    Placebos were administrated as same as the bifidobacterium live capsule

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Incidence of POCD 7days after surgery

    Time frame: The seventh day after surgery

Secondary outcomes

  1. Incidence of POCD 1 month after operation

    Time frame: One month after surgery

  2. Incidence of POD 7 days after surgery

    Use the CAM scale to assess whether a patient has postoperative delirium

    Time frame: One day after surgery to the seventh day after surgery

07

Study locations

3 of 3 sites recruiting
  • Renji Hospital
    Shanghai, Shanghai 200127, China
    Recruiting
  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
    Shanghai, Shanghai, China
    Recruiting
  • Jin Cheng people's hospital
    Jincheng, Shanxi, China
    • Jinping Wang · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04017403
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Jul 12, 2019
Start date
Dec 15, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
May 2, 2022

Study contacts

tang ying, Bachelor
Contact
421941497@qq.com
13918859887 ext. 18616514088
su diansan, Doctor
Contact
184872238@qq.com
18616514088 ext. 18616514088
su diansan
study chair · RenJi Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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