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The preventive effect of probiotics combined with VitB6 on postoperative neurocognitive impairment: a randomized, double-blind, placebo-controlled trial

The preventive effect of probiotics combined with VitB6 on postoperative neurocognitive impairment: a randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061271
Enrollment
Unknown
Registered
2022-06-18
Start date
2023-09-16
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative neurocognitive impairment

Interventions

Experimental group:Probiotics+vitb6 injection+0.9% sodium chloride injection
Control group:Placebo capsule+0.9% sodium chloride injection

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Elective hip/knee replacement patients; 2. Aged 60-80 years old, gender is not limited, race is not limited; 3. Expected hospital stay >= 7 days; 4. No immune system disease; 5. Agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Participating in other clinical trials; 2. The patient underwent multiple (more than one) operations or emergency operations during this hospitalization due to the needs of the patient's condition; 3. Suffering from Parkinson's disease or other neurological diseases that cause dysfunction; 4. Unable to communicate due to coma, severe dementia, language barrier, severe auditory or visual impairment, terminal disease, etc. before operation; 5. Critical condition (preoperative ASA grade >= IV); 6. Have used antibiotics, probiotics, and gastrointestinal motility drugs within 10 days before admission; 7. Severe renal impairment (requiring renal replacement therapy); 8. Severe liver damage (Child-Pugh grade C); 9. The attending doctor or researcher believes that there are other conditions that are not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
delirium;Cognitive ability;

Secondary

MeasureTime frame
Blood inflammation level;

Countries

China

Contacts

Public ContactJiangbin Tong

The Third Xiangya Hospital of Central South University

498836726@qq.com+86 153 8642 9820

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026