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Intestinal Microflora in Lung Cancer After Chemotherapy

Primary Purpose

Lung Cancer, Effects of Chemotherapy, Tumor Immunity

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Probiotics
placebo
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Gut microflora, Lung cancer, Chemotherapy, Immunity, Nutrition

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gastroenterology,Qilu Hospital,Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Microbial composition using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks

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

Outcomes

Primary Outcome Measures

Composition of Microorganisms in stool after probiotic intervention
Primary coordination of fecal samples' 16s(%) rDNA will be compared between two groups using Braycurtis distance based Primary coordination analysis(PCoA)

Secondary Outcome Measures

Frequency and severity of Adverse effects during Chemotherapy
The change of immunity and nutrition index

Full Information

First Posted
July 14, 2015
Last Updated
May 21, 2017
Sponsor
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT02771470
Brief Title
Intestinal Microflora in Lung Cancer After Chemotherapy
Official Title
Intestinal Microflora in Lung Cancer After Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Effects of Chemotherapy, Tumor Immunity, Malnutrition
Keywords
Gut microflora, Lung cancer, Chemotherapy, Immunity, Nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Microbial composition using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Microbiota modulation using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks
Intervention Type
Drug
Intervention Name(s)
Probiotics
Other Intervention Name(s)
containing clostridium butyricum
Intervention Description
Microbial composition using probiotic
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Microbiota modulation using placebo
Primary Outcome Measure Information:
Title
Composition of Microorganisms in stool after probiotic intervention
Description
Primary coordination of fecal samples' 16s(%) rDNA will be compared between two groups using Braycurtis distance based Primary coordination analysis(PCoA)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Frequency and severity of Adverse effects during Chemotherapy
Time Frame
2 months
Title
The change of immunity and nutrition index
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, MD.PhD.
Organizational Affiliation
Qilu Hospital, Shandong University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gastroenterology,Qilu Hospital,Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Intestinal Microflora in Lung Cancer After Chemotherapy

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