| CTRI Number |
CTRI/2025/12/099932 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on the Benefits of Probiotics in Patients Undergoing Colorectal Surgery |
|
Scientific Title of Study
|
Effects of probiotics on the clinical outcome and inflammatory response in colorectal cancer surgery: A double blinded randomized control 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 Vijayakumar C |
| Designation |
Associate Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Associate Professor
Département of Surgery
JIPMER
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry - 605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8526617232 |
| Fax |
|
| Email |
vijaymmc01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayakumar C |
| Designation |
Associate Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Associate Professor
Département of Surgery
JIPMER
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry - 605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8526617232 |
| Fax |
|
| Email |
vijaymmc01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayakumar C |
| Designation |
Associate Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Associate Professor
Département of Surgery
JIPMER
JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry - 605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8526617232 |
| Fax |
|
| Email |
vijaymmc01@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Department of Zoology
Anugrah Memorial College Gaya
Magadh University, Bihar, 824234, India |
|
|
Primary Sponsor
|
| Name |
Anugrah Memorial College Gaya |
| Address |
Department of Zoology
Anugrah Memorial College Gaya
Magadh University, Bihar ,824234, India
|
| Type of Sponsor |
Research institution |
|
|
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 Vijayakumar Chellappa |
Department of Surgery |
Associate Professor, Department of Surgery, JIPMER, Puducherry
Pondicherry
PONDICHERRY |
08526617232
vijaymmc01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - INTERVENTIONAL STUDIES JIPMER, PUDUCHERRY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BIFILACR sachets |
In the Probiotics group, the participants will receive BIFILACR sachets which consists
1. Streptococcus faecalis 30 million per 0.5 gm.
2. Clostridium butryicum 2 million per 0.5 gm.
3. Bacillus mesentricus 1 million per 0.5 gm.
4. Lactobacillus sporogenes 50 million per 0.5gm.
In the Placebo group, participants will receive identical looking placebo sachets.
|
| Comparator Agent |
Placebo sachets |
Participants will receive placebo sachets 3 days before surgery and twice daily for 10 days after the day of surgery thereafter. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.All patients who are more than 18 years of age, with histologically and radiologically diagnosed Sigmoid colon cancer, those who is scheduled for anterior resection
2. Those who have been agreed to participate in this trial (through informed consent) before initiation of clinical trial undergoing surgery for colorectal cancer
|
|
| ExclusionCriteria |
| Details |
1. Those who have metastatic colorectal cancer
2. Those who have urinary incontinence or fecal incontinence
3. Those who received preoperative chemotherapy or radiotherapy
4. Those who have a history of severe cerebral vascular disease (cerebral infarction, cerebral hemorrhage, etc.), severe cardiac disease (unstable angina pectoris, myocardial infarction, arrhythmia requiring heart failure heart failure therapy)
5. Those who have neurologist or psychologically important psychiatric history or current disease
6. Those who have alcohol addiction, substance abuse
7. Those who have Immune system, infectious disease, gastrointestinal tract disease patients (inflammatory bowel disease)
8. Those who have uncontrolled hypertension, diabetes patients
9. Those who have creatinine with more than twice from normal upper limit in site
10. Those who have AST(GOT) or ALT(GPT) with more than three times from normal upper limit in site
11. Those who have probiotics, antibiotics, continually within the last one week
12. Those who is pregnant women, breastfeeding women and have pregnancy plans or do not agree to appropriate contraception methods choice
13. Those who have been participated within three months or have plans to participate in another clinical trial after the start of this clinical trial
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine if the administration of probiotic will improve in anterior resection syndrome score (ARS) in patients undergoing surgical resection for colorectal cancer. |
Baseline: The day of admission
Before Surgery; One day before surgery: After the administration of antibiotics and mechanical bowel preparation agents;
Postoperative Day 10 (POD-10): Ten days after surgery and Postoperative; Day 17(POD17) One week after discontinuation of probiotics/placebo.
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
05/01/2027 |
| 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 Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vijaymmc01@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Intervention Groups Probiotic Group Group A
Participants will receive two sachets of probiotic powder mixed with 10 to 15 ml of saline or water twice daily for 3 days prior to surgery. Postoperatively, the same preparation will be administered within 24 hours of surgery. After resumption of oral intake, the probiotics will be continued orally to complete a total duration of 14 days 3 preoperative plus 11 postoperative days. Placebo Group Group B
Participants will receive two sachets of saline mixed placebo identical in appearance and dosing schedule to the probiotic group. Preoperative Assessment A dedicated proforma will be used to record the following
Demographic details
Tumor stage
Surgical details
Fecal microbiota profile
Nutritional status including hemoglobin BMI albumin transferrin
Quality of life measures
Inflammatory markers including TLC IL6 IL8 TNF alpha measured using ELISA kits Primary Endpoint The primary endpoint will be assessed using the Anterior Resection Syndrome ARS Score Questionnaire. Secondary Endpoints Fecal Microbiome Analysis Bacterial composition analysis and next generation sequencing reference 29
This analysis will evaluate the impact of surgery antibiotics and probiotics on gut microbiota. Fecal samples will be analyzed at the phylum and genus levels. Bacteria will be classified into
Set I Beneficial bacteria including Bifidobacterium Lactobacillus Akkermansia
Set II Pathogenic bacteria including Prevotella Fusobacterium Laboratory methods will include
DNA extraction from fecal samples
PCR amplification of the V3 V4 region of the 16S rRNA gene followed by sequencing using the Illumina MiSeq platform
Full length 16S rRNA sequencing using 27F and 1492R primers on a PacBio RS II sequencer Microbial diversity analysis will include
QIIME software
Shannon diversity index
Redundancy Analysis RDA
Operational Taxonomic Units OTUs Fecal sample collection time points
Baseline day of admission
Preoperative one day prior to surgery after antibiotics and bowel preparation
Postoperative Day 10 POD10
Postoperative Day 17 POD17 one week after stopping probiotics or placebo Samples will be stored at minus 80 degrees Celsius and transported to an external laboratory in a blinded manner. DNA extraction and purification will follow validated published protocols. Quality of Life Assessment Quality of life will be assessed at
Preoperative baseline
Postoperative follow up The EORTC QLQC30 questionnaire will be used for evaluation reference 30. Postoperative Assessment POD10 On POD10 blood samples will be repeated to assess
Nutritional status
Inflammatory markers including
Glasgow Prognostic Score GPS
White blood cell count
Neutrophil lymphocyte monocyte and platelet counts
Neutrophil to lymphocyte ratio NLR
Cytokines including TNF alpha IFN gamma IL6 IL10 Postoperative Complications Complications will be classified according to the Clavien Dindo classification. Postoperative Clinical Outcomes The following outcomes will be documented
Time to first flatus
Time to first passage of stools
Time to initiation of oral diet
Duration of drain placement
Duration of antibiotic therapy
Length of hospital stay defined from one day prior to surgery until the patient is fit for discharge based on normal diet tolerance and satisfactory wound healing
In hospital mortality Postoperative complications to be recorded include
Surgical site infection SSI
Anastomotic leak as per CDC criteria
Diarrhea
Fever
Urinary tract infection UTI
Lung infection Follow Up Protocol Early Discharge Follow Up
Participants discharged before completing 10 days of therapy will continue probiotics or placebo at home. They will return on postoperative Day 10 for assessment of postoperative outcomes. Postoperative Day 30 Follow Up
A follow up assessment at POD30 either in person or via telephone will document late postoperative complications. |