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Effects of probiotics in preventing alterations in behaviour, attention, memory and General understanding after surgery in elderly patients undergoing hip or knee replacement surgery

To evaluate the effects of perioperative oral probiotic in preventing perioperative neurocognitive disorders among elderly patients following hip or knee arthroplasty: A randomised controlled trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072798
Enrollment
250
Registered
2024-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: M96-M96- Intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified

Interventions

Intervention1: Probiotics: 2 weeks before surgery to 2 weeks post surgery Control Intervention1: Placebo: 2 weeks before surgery to 2 weeks post surgery

Sponsors

Dr Sneha Sharma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age above 60 years. Undergoing total hip or knee arthroplasty Can give informed consent themselves Able to communicate

Exclusion criteria

Exclusion criteria: Patients with a history suggestive of dementia (either listed in the medical record or reported by the patient) or any neurological disorder. History of alcohol abuse, chronic opioid or other substance abuse History of cerebral surgeries, stroke. History suggestive of psychiatric disease like schizophrenia, dementia, anxiety or other disorder affecting cognition, mental dysfunction Prescription of central nervous system–active medications (eg:antidepressants, antipsychotics, sedatives) Patient already on probiotics/ prebiotic/ synbiotic.

Design outcomes

Primary

MeasureTime frame
To compare the incidence of postoperative neurocognitive disorders between probiotic and placebo group.Timepoint: Patient will be assessed for cognitive function one day before surgery,24 hrs post surgery and 2 weeks post surgery

Secondary

MeasureTime frame
To determine the association between probiotics and neuroinflammatory marker ( BDNF and MDA) Timepoint: One day before surgery 24 hrs and 2 weeks post surgery

Countries

India

Contacts

Public ContactDr Puneet Khanna

All India Institute of Medical Sciences New Delhi

k.punit@yahoo.com9873106516

Outcome results

None listed

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