Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy

Shandong University

Status and phase: Unknown; Phase 1

Conditions: Malnutrition; Tumor Immunity; Effects of Chemotherapy; Gastrointestinal Neoplasms; Colorectal Cancer

Treatments: Drug: placebo（for probiotic）; Drug: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT02169388

2014SDU-QILU-G03

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

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

Treatment:

Drug: Probiotic

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo（for probiotic）