Intestinal Microflora in Lung Cancer After Chemotherapy

NCT ID: NCT02771470

Last Updated: 2017-05-23

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-07-31

Brief Summary

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Probiotics modulate the gut microflora and immune status in lung cancer who need chemotherapy.

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.

Conditions

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Lung 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 probiotics,3 capsules/times,3 times/day for 3 to 4 weeks

Group Type EXPERIMENTAL

Probiotics

Intervention Type DRUG

Microbial composition using probiotic

Placebo

Microbiota modulation using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Microbiota modulation using placebo

Interventions

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Probiotics

Microbial composition using probiotic

Intervention Type DRUG

placebo

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 of lung cancer

Exclusion Criteria

* Antibiotic, probiotic or prebiotic usage within 1month
* Other malignancy
* History of abdominal surgery
* Pregnant or breast-feeding (for females)
* Impaired liver or renal function
* Diabetes, thyroid disorder, coagulopathy or bleeding disorders, mental disorder
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: STUDY_CHAIR

Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2014SDU-QILU-G06

Identifier Type: -

Identifier Source: org_study_id

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