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Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02169388
Recruitment Status : Unknown
Verified June 2014 by Yanqing Li, Shandong University.
Recruitment status was:  Recruiting
First Posted : June 23, 2014
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Yanqing Li, 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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : January 2015

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




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. Frequency and severity of Adverse effects during Chemotherapy [ Time Frame: 5 months ]
    Adverse effects includes vomiting, nausea, diarrhea and abdominal pain.


Secondary Outcome Measures :
  1. 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).

  2. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169388


Contacts
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Contact: Yanqing Li, MD.PhD. 86-531-82169236 ext 82169508 liyanqing@sdu.edu.cn

Locations
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China, Shandong
Department of Gastroenterology,Qilu Hospital,Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yanqing Li, MD.PhD.    86-531-82169236 ext 82169508    liyanqing@sdu.edu.cn   
Principal Investigator: Yanqing Li, MD.PhD.         
Sub-Investigator: Ming Li, MD         
Sub-Investigator: Yang Tian, MD         
Sponsors and Collaborators
Shandong University
Investigators
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Principal Investigator: Yanqing Li, MD.PhD Qilu Hospital,Shandong University
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Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT02169388    
Other Study ID Numbers: 2014SDU-QILU-G03
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014
Keywords provided by Yanqing Li, Shandong University:
Gut microflora
colorectal cancer
Chemotherapy
Immunity
Nutrition
Additional relevant MeSH terms:
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Colorectal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Malnutrition
Intestinal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Nutrition Disorders