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CTRI Number  CTRI/2026/03/106336 [Registered on: 16/03/2026] Trial Registered Prospectively
Last Modified On: 29/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Advantage of Probiotics in enhancing Gastric emptying in Diabetics undergoing Cancer resection surgery 
Scientific Title of Study   Gastric Ultrasonography to assess the effect of Probiotics on Gastric residual volume in Diabetic patients planned for Cancer resection surgery: A Randomised Controlled Trial 
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 Sambit Nandi 
Designation  DM-Senior Resident 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 
Address  DrBRA IRCH CAMPUS, ANSARI NAGAR, EAST NEW DELHI, DELHI, 110029, India

New Delhi
DELHI
110029
India 
Phone  7809425800  
Fax    
Email  nandi.sambit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saurabh Vig 
Designation  Associate Professor 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 
Address  DrBRA IRCH CAMPUS, ANSARI NAGAR, EAST NEW DELHI, DELHI, 110029, India

New Delhi
DELHI
110029
India 
Phone  9538247725  
Fax    
Email  saurabh377@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DR SUSHMA BHATNAGAR 
Designation  PROFESSOR AND HEAD 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI 
Address  DrBRA IRCH CAMPUS, ANSARI NAGAR, EAST NEW DELHI, DELHI, 110029, INDIA

New Delhi
DELHI
110029
India 
Phone  9811326453  
Fax    
Email  sushmabhatnagar1@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  DR BRA IRCH AIIMS CAMPUS, ANSARI NAGAR, EAST NEW DELHI, DELHI Pin code-110029 
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 Sambit Nandi  Operation theatre 6th floor, All India Institute of Medical Sciences  DR BRA IRCH , AIIMS CAMPUS, Ansari Nagar, East New Delhi, DELHI
New Delhi
DELHI 
7809425800

nandi.sambit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee -AIIMS Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NO Probiotics  No Probiotics, Only keep NPO as per Standard NPO guidelines before surgery 
Intervention  Probiotics drink  1 sachet of Sporlac powder (each sachet contains NLT 150 million spores of lactic acid bacillus) mixed with 200ml water to be taken at bedtime for 7 nights prior to surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. diabetic patients
2. age between 18 to 70 years
3. HBa1C level less than 8
4. undergoing Non-GI surgery 
 
ExclusionCriteria 
Details  1. Refusal to participate
2.Previous history of gastric surgery
3. Any other condition associated with delayed gastric emptying
4. Unable to take orally 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the effect of probiotics on gastric residual volume evaluated ultrasonographically in diabetics undergoing cancer resection surgery
 
Probiotics drink started 7 days prior to surgery and continued till the night before surgery. Gastric residual volume estimated on the day of surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
1) To measure the difference in Perlas grading between both groups
2) To determine the ease of obtaining USG parameters
3) To calculate the correlation between preoperative HbA1c & the beneficial effect of Probiotics 
On the day of surgery in the preoperative area 
 
Target Sample Size   Total Sample Size="146"
Sample Size from India="146" 
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)   27/03/2026 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Diabetic patients are prone to have gastroparesis with increased gastric content. A full stomach is a well-known risk factor for aspiration in the perioperative period and the development of postoperative pulmonary complications.Little is known about the pathophysiology of gastroparesis in diabetics. Duodenal micro-inflammation due to dysbiosis is one of the pathological signatures of gut-brain axis alterations thought to be responsible for gastroparesis. Probiotics helps in maintaining gut microbiota and thus in preventing gastroparesis. Gastric ultrasound (USG) is non-invasive, easy to perform at the bedside with minimal discomfort,and avoids radiation exposure. It also provides reliable quantitative and qualitative information about the nature of gastric contents before anesthesia. Thus, it is a useful tool for assessing the risk of pulmonary aspiration, which has greatly altered clinical management during anesthesia. Gastric volume measured by USG is a good parameter to establish gastric emptying. Thus we hypothesize that preoperative ingestion of probiotics will decrease residual gastric volume.

 
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