Probiotics Attenuate Postoperative Cognition Decline

NCT ID: NCT04017403

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-15

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Bifidobacterium triple live capsule

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placebos were administrated as same as the bifidobacterium live capsule

Interventions

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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.

Intervention Type DRUG

Placebos

Placebos were administrated as same as the bifidobacterium live capsule

Intervention Type DRUG

Other Intervention Names

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Peifei Kang Capsule Placebo

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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su diansan

Role: STUDY_CHAIR

RenJi Hospital

Locations

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Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Jin Cheng people's hospital

Jincheng, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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tang ying, Bachelor

Role: CONTACT

13918859887 ext. 18616514088

su diansan, Doctor

Role: CONTACT

18616514088 ext. 18616514088

Facility Contacts

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diansan su, Dr.

Role: primary

+862168383702

Xiaoxue Hu

Role: primary

Jinping Wang

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36841790 (View on PubMed)

Other Identifiers

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PAPOCD

Identifier Type: -

Identifier Source: org_study_id

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