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Intestinal Microflora in Lung Cancer After Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02771470
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : May 23, 2017
Information provided by (Responsible Party):
Yanqing Li, Shandong University

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

Condition or disease Intervention/treatment Phase
Lung Cancer Effects of Chemotherapy Tumor Immunity Malnutrition Drug: Probiotics Drug: placebo 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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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 Name: 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

Primary Outcome Measures :
  1. 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)

Secondary Outcome Measures :
  1. Frequency and severity of Adverse effects during Chemotherapy [ Time Frame: 2 months ]
  2. The change of immunity and nutrition index [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02771470

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China, Shandong
Department of Gastroenterology,Qilu Hospital,Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
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Study Chair: Yanqing Li, MD.PhD. Qilu Hospital,Shandong University

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Responsible Party: Yanqing Li, Vice president of Qilu Hospital, Shandong University Identifier: NCT02771470     History of Changes
Other Study ID Numbers: 2014SDU-QILU-G06
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yanqing Li, Shandong University:
Gut microflora
Lung cancer

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Nutrition Disorders