Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy
Conditions
Gastrointestinal Neoplasms - Colorectal Cancer - Effects of Chemotherapy - Tumor Immunity - Malnutrition
Conditions: official terms
Colorectal Neoplasms - Digestive System Neoplasms - Gastrointestinal Neoplasms - Malnutrition
Conditions: Keywords
Gut microflora, colorectal cancer, Chemotherapy, Immunity, Nutrition
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Intervention
Name: Probiotic Type: Drug
Name: placebo(for probiotic) Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Department of Gastroenterology,Qilu Hospital,Shandong University
Jinan, Shandong, China
Status: Recruiting
Contact: Yanqing Li, MD.PhD. - 86-531-82169236 - liyanqing@sdu.edu.cn
Start Date
June 2014
Completion Date
January 2015
Sponsors
Shandong University
Source
Shandong University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page