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Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy

Primary Purpose

Gastrointestinal Neoplasms, Colorectal Cancer, Effects of Chemotherapy

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Probiotic
placebo（for probiotic）
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastrointestinal Neoplasms focused on measuring Gut microflora, colorectal cancer, Chemotherapy, Immunity, Nutrition

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gastroenterology,Qilu Hospital,Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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.
Frequency and severity of Adverse effects during Chemotherapy
Adverse effects includes vomiting, nausea, diarrhea and abdominal pain.

Secondary Outcome Measures

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).
The observed changes in nutritional status after chemotherapy
Nutritional status indexes include BMI, percentage of body weight changes, plasma albumin and prealbumin.

Full Information

First Posted
June 4, 2014
Last Updated
June 24, 2014
Sponsor
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT02169388
Brief Title
Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy
Official Title
Effects of Gut Microflora on the Immune and Nutritional Status of CRC Patients After Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
January 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms, Colorectal Cancer, Effects of Chemotherapy, Tumor Immunity, Malnutrition
Keywords
Gut microflora, colorectal cancer, Chemotherapy, Immunity, Nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Microbial composition using Probiotic，3 capsules / times, 2 times / day for 4 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Microbiota modulation using placebo，3 capsules / times, 2 times / day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Probiotic
Other Intervention Name(s)
containing, （ clostridium butyricum）
Intervention Description
Microbial composition using probiotic
Intervention Type
Drug
Intervention Name(s)
placebo（for probiotic）
Intervention Description
microbiota modulation using placebo
Primary Outcome Measure Information:
Title
Composition of Microorganisms in stool after probiotic intervention
Description
Primary coordination of fecal samples' 16s rDNA (ribosomal DNA) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA).
Time Frame
5 months
Title
Short-chain fatty acids in feces of patients after chemotherapy
Description
The total concentration of Short-chain fatty acids in the in feces of patients after chemotherapy.
Time Frame
5 months
Title
Frequency and severity of Adverse effects during Chemotherapy
Description
Adverse effects includes vomiting, nausea, diarrhea and abdominal pain.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
The observed changes in immune status after chemotherapy
Description
Immune status indexes include percentage of Neutrophils, total lymphocytes, lymphocyte subgroups, plasma immunoglobulin level, CRP (C reactive protein).
Time Frame
5 month
Title
The observed changes in nutritional status after chemotherapy
Description
Nutritional status indexes include BMI, percentage of body weight changes, plasma albumin and prealbumin.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanqing Li, MD.PhD.
Phone
86-531-82169236
Ext
82169508
Email
liyanqing@sdu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, MD.PhD
Organizational Affiliation
Qilu Hospital, Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology,Qilu Hospital,Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, MD.PhD.
Phone
86-531-82169236
Ext
82169508
Email
liyanqing@sdu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yanqing Li, MD.PhD.
First Name & Middle Initial & Last Name & Degree
Ming Li, MD
First Name & Middle Initial & Last Name & Degree
Yang Tian, MD

12. IPD Sharing Statement

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Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy

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