Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy

Sponsor

Shandong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02169388

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Neoplasms Colorectal Cancer Effects of Chemotherapy Tumor Immunity Malnutrition	Drug: Probiotic Drug: placebo（for probiotic）	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

Oct 1, 2014

Anticipated Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotic Microbial composition using Probiotic，3 capsules / times, 2 times / day for 4 weeks	Drug: Probiotic Microbial composition using probiotic Other Names: containing （ clostridium butyricum）
Placebo Comparator: placebo Microbiota modulation using placebo，3 capsules / times, 2 times / day for 4 weeks	Drug: placebo（for probiotic） microbiota modulation using placebo

Arm

Intervention/Treatment

Experimental: Probiotic

Microbial composition using Probiotic，3 capsules / times, 2 times / day for 4 weeks

Drug: Probiotic

Microbial composition using probiotic

Other Names:

containing

（ clostridium butyricum）

Placebo Comparator: placebo

Microbiota modulation using placebo，3 capsules / times, 2 times / day for 4 weeks

Drug: placebo（for probiotic）

microbiota modulation using placebo

Outcome Measures

Primary Outcome Measures

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

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.