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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02169388
Other study ID # 2014SDU-QILU-G03
Secondary ID
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


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
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