Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02169388
• Other study ID #: 2014SDU-QILU-G03
• Status: Recruiting
• Phase: Phase 1
• First received: June 4, 2014
• Last updated: June 24, 2014
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: June 2014
• Source: Shandong University
• Contact: Yanqing Li, MD.PhD.
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Digestive System Neoplasms
• Effects of Chemotherapy
• Gastrointestinal Neoplasms
• Malnutrition
• Tumor Immunity

Intervention

Drug:
• Probiotic
Microbial composition using probiotic
• placebo(for probiotic)
microbiota modulation using placebo

Locations

Country	Name	City	State
China	Department of Gastroenterology,Qilu Hospital,Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	5 months	No
Primary	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.	5 months	No
Primary	Frequency and severity of Adverse effects during Chemotherapy	Adverse effects includes vomiting, nausea, diarrhea and abdominal pain.	5 months	No
Secondary	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).	5 month	No
Secondary	The observed changes in nutritional status after chemotherapy	Nutritional status indexes include BMI, percentage of body weight changes, plasma albumin and prealbumin.	5 months	No