A prospective, single-center, randomized, interventional, open-label, two-arm study to assess the impact of gut microbiome modulation in patients undergoing interventional spine procedures.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- To evaluate the effect of short-term gut microbiome prehabilitation using probiotics on postoperative pain, sleep quality, and insomnia; assess cognitive dysfunction, anxiety, dysgeusia, analgesic use in the first week, changes in inflammatory markers, and health status and quality of life via the SF-36 questionnaire.
Study Overview
Brief Summary
This prospective, randomized, interventional, open-label, two-arm study aims to evaluate the impact of short-term gut microbiome modulation using probiotics in patients undergoing interventional spine procedures. Conducted at a single center, the trial will enroll 80 participants aged 18–80 years, randomized into intervention and control groups. The intervention group will receive probiotics for 7 days preoperatively and 13 days postoperatively, while the control group will receive standard care. The study will assess primary outcomes including pain intensity, sleep quality, insomnia, cognitive dysfunction, anxiety, dysgeusia, inflammatory markers, and overall health status using the SF-36 questionnaire. Secondary outcomes will focus on gastrointestinal symptoms such as diarrhea, constipation, nausea, vomiting, abdominal distention, and flatulence. The trial duration is two years and is designed to generate evidence supporting the role of probiotics in enhancing perioperative recovery and patient well-being.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of all genders aged 18–80 years, scheduled for interventional spine procedures.
- •Patients capable of providing informed consent and adhering to the study protocols.
- •Individuals classified as ASA (American Society of Anaesthesiologists) physical status 1–
- •Patients without significant preoperative cognitive dysfunction.
Exclusion Criteria
- •Patients with difficulty in effective communication or understanding.
- •Patients with significant neurological disorders with cognitive impairment, such as Alzheimer’s disease, stroke, or psychosis.
- •Patients with a prolonged nil-by-mouth status exceeding 48 hours pre- and post-surgery.
- •Patients regularly consuming probiotics prior to the planned surgical procedure.
Outcomes
Primary Outcomes
To evaluate the effect of short-term gut microbiome prehabilitation using probiotics on postoperative pain, sleep quality, and insomnia; assess cognitive dysfunction, anxiety, dysgeusia, analgesic use in the first week, changes in inflammatory markers, and health status and quality of life via the SF-36 questionnaire.
Time Frame: Patients will be monitored at specific time points of 1 day before the procedure, 1 day post-operatively, 2 days postoperatively, 3 days postoperatively, 7 days postoperatively and at the timepoint of discharge
Secondary Outcomes
- To evaluate the effect of using probiotics on gastrointestinal outcomes in the postoperative period, including the incidence of postoperative diarrhea, constipation, vomiting, nausea, abdominal distention, and flatulence.(Patients will be monitored at specific time points of 1 day before the procedure, 1 day post-operatively, 2 days postoperatively, 3 days postoperatively, 7 days postoperatively and at the timepoint of discharge)