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CTRI Number  CTRI/2025/06/089436 [Registered on: 24/06/2025] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to evaluate the effect of gut microbiome changes in patients undergoing spine procedures. 
Scientific Title of Study   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 Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vivek Kulkarni  
Designation  Consultant Anesthesiologist 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPD No. 1, D Wing, Department of Anesthesia, Second Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.

Thane
MAHARASHTRA
401107
India 
Phone  9930073471  
Fax    
Email  drvivek.k@bhaktivedantahospital.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Kulkarni  
Designation  Consultant Anesthesiologist 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPD No. 1, D Wing, Department of Anesthesia, Second Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.

Thane
MAHARASHTRA
401107
India 
Phone  9930073471  
Fax    
Email  drvivek.k@bhaktivedantahospital.com  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Kulkarni  
Designation  Consultant Anesthesiologist 
Affiliation  Bhaktivedanta Hospital and Research Institute 
Address  OPD No. 1, D Wing, Department of Anesthesia, Second Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.

Thane
MAHARASHTRA
401107
India 
Phone  9930073471  
Fax    
Email  drvivek.k@bhaktivedantahospital.com  
 
Source of Monetary or Material Support  
Bhaktivedanta Hospital and Research Institute, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107. 
 
Primary Sponsor  
Name  Bhaktivedanta Hospital and Research Institute 
Address  Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vivek Kulkarni   Bhaktivedanta Hospital and Research Institute  OPD No. 1, D Wing, Department of Anesthesia,Second Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA 		 9930073471

drvivek.k@bhaktivedantahospital.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 the procedure).  
Comparator Agent  Standard of care  Patients in the control group will receive standard pre as well as postoperative care as practiced in the tertiary healthcare facility. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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.  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 Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
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