Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Probiotics modulate the gut microflora and immune status in CRC,which can reduce the side effects of chemotherapy such as diarrhea,infection,neutropenia etc.

Detailed Description
-----------------
Chemotherapy destroys the intestinal mucosal barrier, affects intestinal flora, causing bacterial translocation, infection and other complications; Probiotics may restore the intestinal immunity, mucosal barrier, and nutrient absorption.The adverse effects of chemotherapy and the malnutrition status may be relieved via probiotic administration.

Official Title
-----------------
Effects of Gut Microflora on the Immune and Nutritional Status of CRC Patients After Chemotherapy

Conditions
-----------------
Gastrointestinal Neoplasms, Colorectal Cancer, Effects of Chemotherapy, Tumor Immunity, Malnutrition

Intervention / Treatment
-----------------
* Drug: Probiotic
* Drug: placebo（for probiotic）


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for chemotherapy after radical resection of colorectal cancer Exclusion Criteria: Palliative resection of colorectal cancer Antibiotic,probiotic or prebiotic usage within 1months Other malignancy History of other abdominal surgery Coagulopathy or bleeding disorders Pregnant or breast-feeding(for females) Impaired liver or renal function

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic<br>Microbial composition using Probiotic，3 capsules / times, 2 times / day for 4 weeks | Drug: Probiotic<br>* Microbial composition using probiotic<br>* Other names: （ clostridium butyricum）;|
| Placebo Comparator: placebo<br>Microbiota modulation using placebo，3 capsules / times, 2 times / day for 4 weeks | Drug: placebo（for probiotic）<br>* microbiota modulation using placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composition of Microorganisms in stool after probiotic intervention | Primary coordination of fecal samples' 16s rDNA (ribosomal DNA) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA). | 5 months | 
| Short-chain fatty acids in feces of patients after chemotherapy | The total concentration of Short-chain fatty acids in the in feces of patients after chemotherapy. | 5 months | 
| Frequency and severity of Adverse effects during Chemotherapy | Adverse effects includes vomiting, nausea, diarrhea and abdominal pain. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The observed changes in immune status after chemotherapy | Immune status indexes include percentage of Neutrophils, total lymphocytes, lymphocyte subgroups, plasma immunoglobulin level, CRP (C reactive protein). | 5 month | 
| The observed changes in nutritional status after chemotherapy | Nutritional status indexes include BMI, percentage of body weight changes, plasma albumin and prealbumin. | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gut microflora, colorectal cancer, Chemotherapy, Immunity, Nutrition