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A study to evaluate the effect of gut microbiome changes in patients undergoing spine procedures.

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089436
Enrollment
80
Registered
2025-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Probiotics: Patients in the intervention group will receive probiotics provided by the Investigator, administered once daily for 20 days (7 days prior to the procedure and 13 days post

Sponsors

Bhaktivedanta Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of all genders aged 18 80 years, scheduled for interventional spine procedures. 2. Patients capable of providing informed consent and adhering to the study protocols. 3. Individuals classified as ASA (American Society of Anaesthesiologists) physical status 1 4. 4. Patients without significant preoperative cognitive dysfunction.

Exclusion criteria

Exclusion criteria: 1. Patients with difficulty in effective communication or understanding. 2. Patients with significant neurological disorders with cognitive impairment, such as Alzheimer s disease, stroke, or psychosis. 3. Patients with a prolonged nil-by-mouth status exceeding 48 hours pre- and post-surgery. 4. Patients regularly consuming probiotics prior to the planned surgical procedure.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 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

MeasureTime frame
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.Timepoint: 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—

Countries

India

Contacts

Public ContactDr Vivek Kulkarni

Bhaktivedanta Hospital and Research Institute

drvivek.k@bhaktivedantahospital.com9930073471

Outcome results

None listed

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