Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy

June 24, 2014 updated by: Yanqing Li, Shandong University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Gastroenterology,QiLu Hospital,Shandong University
        • Sub-Investigator:
          • Ming Li, MD
        • Contact:
        • Principal Investigator:
          • Yanqing Li, MD.PhD.
        • Sub-Investigator:
          • Yang Tian, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composition of Microorganisms in stool after probiotic intervention
Time Frame: 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).
5 months
Short-chain fatty acids in feces of patients after chemotherapy
Time Frame: 5 months
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
Time Frame: 5 months
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
Time Frame: 5 month
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
Time Frame: 5 months
Nutritional status indexes include BMI, percentage of body weight changes, plasma albumin and prealbumin.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Principal Investigator: Yanqing Li, MD.PhD, Qilu Hospital, Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

October 1, 2014

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 18, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Estimate)

June 25, 2014

Last Update Submitted That Met QC Criteria

June 24, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014SDU-QILU-G03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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