| 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
|
|
|
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
|
|
|
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
|
|
|
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. |