Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy

Phase 1

• Conditions: Gastrointestinal Neoplasms; Colorectal Cancer; Effects of Chemotherapy; Tumor Immunity; Malnutrition
• Interventions: Drug: Probiotic; Drug: placebo（for probiotic）

• Registration Number: NCT02169388
• Lead Sponsor: Shandong University

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.

Study Timeline

• Status Verified: 2014-06
• Study Start: 2014-06
• Study First Submitted: 2014-06-04
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-23
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-25
• Primary Completion: 2014-10
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Microbial composition using Probiotic，3 capsules / times, 2 times / day for 4 weeks
placebo	placebo（for probiotic）	Microbiota modulation using placebo，3 capsules / times, 2 times / day for 4 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Gastroenterology,Qilu Hospital,Shandong University; 🇨🇳 Jinan, Shandong, China