Intestinal Microflora in Lung Cancer After Chemotherapy

May 21, 2017 updated by: Yanqing Li, Shandong University
Probiotics modulate the gut microflora and immune status in lung cancer who need chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Department of Gastroenterology,Qilu Hospital,Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Probiotic
Microbial composition using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks
Drug: Probiotics
Microbial composition using probiotic
Other Names:
  • containing clostridium butyricum
PLACEBO_COMPARATOR: Placebo
Microbiota modulation using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks
Drug: placebo
Microbiota modulation using placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composition of Microorganisms in stool after probiotic intervention
Time Frame: 2 months
Primary coordination of fecal samples' 16s(%) rDNA will be compared between two groups using Braycurtis distance based Primary coordination analysis(PCoA)
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency and severity of Adverse effects during Chemotherapy
Time Frame: 2 months
2 months
The change of immunity and nutrition index
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Study Chair: Yanqing Li, MD.PhD., Qilu Hospital, Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

July 14, 2015

First Submitted That Met QC Criteria

May 10, 2016

First Posted (ESTIMATE)

May 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 21, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014SDU-QILU-G06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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