Colorectal Cancer, Effects of Chemotherapy, Gastrointestinal Neoplasms, Malnutrition, Tumor Immunity
Conditions
Keywords
Gut microflora, colorectal cancer, Chemotherapy, Immunity, Nutrition
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.
Interventions
DRUGProbiotic
Microbial composition using probiotic
DRUGplacebo（for probiotic）
microbiota modulation using placebo
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composition of Microorganisms in stool after probiotic intervention | 5 months | Primary coordination of fecal samples' 16s rDNA (ribosomal DNA) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA). |
| Short-chain fatty acids in feces of patients after chemotherapy | 5 months | The total concentration of Short-chain fatty acids in the in feces of patients after chemotherapy. |
| Frequency and severity of Adverse effects during Chemotherapy | 5 months | Adverse effects includes vomiting, nausea, diarrhea and abdominal pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The observed changes in immune status after chemotherapy | 5 month | Immune status indexes include percentage of Neutrophils, total lymphocytes, lymphocyte subgroups, plasma immunoglobulin level, CRP (C reactive protein). |
| The observed changes in nutritional status after chemotherapy | 5 months | Nutritional status indexes include BMI, percentage of body weight changes, plasma albumin and prealbumin. |
Countries
China
Contacts
Primary ContactYanqing Li, MD.PhD.
Outcome results
None listed