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Intestinal Microflora in Lung Cancer After Chemotherapy

Sponsor
Shandong University (Other)
Overall Status
Completed
CT.gov ID
NCT02771470
Collaborator
(none)
41
Enrollment
1
Location
2
Arms
22
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
41 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Intestinal Microflora in Lung Cancer After Chemotherapy
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Jul 1, 2016
Actual Study Completion Date :
Jul 1, 2016

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Composition of Microorganisms in stool after probiotic intervention [2 months]

      Primary coordination of fecal samples' 16s(%) rDNA will be compared between two groups using Braycurtis distance based Primary coordination analysis(PCoA)

    Secondary Outcome Measures

    1. Frequency and severity of Adverse effects during Chemotherapy [2 months]

    2. The change of immunity and nutrition index [2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Gastroenterology,Qilu Hospital,Shandong University Jinan Shandong China 250012

    Sponsors and Collaborators

    • Shandong University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanqing Li, Vice president of Qilu Hospital, Shandong University
    ClinicalTrials.gov Identifier:
    NCT02771470
    Other Study ID Numbers:
    • 2014SDU-QILU-G06
    First Posted:
    May 13, 2016
    Last Update Posted:
    May 23, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Yanqing Li, Vice president of Qilu Hospital, Shandong University
    Gut microflora
    Lung cancer
    Chemotherapy
    Immunity
    Nutrition
    Additional relevant MeSH terms:
    Lung Neoplasms
    Malnutrition

    Study Results

    No Results Posted as of May 23, 2017