Intestinal Microflora in Colorectal Cancer (CRC) After Chemotherapy

NCT ID: NCT02169388

Last Updated: 2014-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Gastrointestinal Neoplasms Colorectal Cancer Effects of Chemotherapy Tumor Immunity Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Probiotic

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

Group Type EXPERIMENTAL

Probiotic

Intervention Type DRUG

Microbial composition using probiotic

placebo

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

Group Type PLACEBO_COMPARATOR

placebo(for probiotic)

Intervention Type DRUG

microbiota modulation using placebo

Interventions

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Probiotic

Microbial composition using probiotic

Intervention Type DRUG

placebo(for probiotic)

microbiota modulation using placebo

Intervention Type DRUG

Other Intervention Names

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containing ( clostridium butyricum)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanqing Li, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yanqing Li, MD.PhD.

Role: CONTACT

86-531-82169236 ext. 82169508

Facility Contacts

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Yanqing Li, MD.PhD.

Role: primary

86-531-82169236 ext. 82169508

Other Identifiers

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2014SDU-QILU-G03

Identifier Type: -

Identifier Source: org_study_id

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