Effects of probiotics on the clinical outcome and inflammatory response in colorectal cancer surgery: A double blinded randomized control trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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
- •Those who have been agreed to participate in this trial (through informed consent) before initiation of clinical trial undergoing surgery for colorectal cancer.
排除标准
- •Those who have metastatic colorectal cancer
- •Those who have urinary incontinence or fecal incontinence
- •Those who received preoperative chemotherapy or radiotherapy
- •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)
- •Those who have neurologist or psychologically important psychiatric history or current disease
- •Those who have alcohol addiction, substance abuse
- •Those who have Immune system, infectious disease, gastrointestinal tract disease patients (inflammatory bowel disease)
- •Those who have uncontrolled hypertension, diabetes patients
- •Those who have creatinine with more than twice from normal upper limit in site
- •Those who have AST(GOT) or ALT(GPT) with more than three times from normal upper limit in site
- •Those who have probiotics, antibiotics, continually within the last one week
- •Those who is pregnant women, breastfeeding women and have pregnancy plans or do not agree to appropriate contraception methods choice
- •Those who have been participated within three months or have plans to participate in another clinical trial after the start of this clinical trial.
研究者
Dr Vijayakumar C
JIPMER, Puducherry