Health Condition 1: C19- Malignant neoplasm of rectosigmoidjunction
Conditions
Interventions
Intervention1: 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 mil
Sponsors
Anugrah Memorial College Gaya
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if the administration of probiotic will improve in anterior resection syndrome score (ARS) in patients undergoing surgical resection for colorectal cancer.Timepoint: 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
| Measure | Time frame |
|---|---|
| Timepoint: | — |
Countries
India
Contacts
Public ContactDr Vijayakumar C
JIPMER, Puducherry
Outcome results
None listed