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Completed

NCT Number: NCT02771470

Intestinal Microflora in Lung Cancer After Chemotherapy

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

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Key information

Conditions

Lung Cancer Effects of Chemotherapy Lung Diseases Lung Neoplasms Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Tumor Immunity

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Drug

Microbial composition using probiotic

Other names: containing clostridium butyricum

Placebo

Drug

Microbiota modulation using placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 13, 2016
Registry last updated
May 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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