Intestinal Microflora in Lung Cancer After Chemotherapy

Lung Cancer Clinical Trial

Official title:

Intestinal Microflora in Lung Cancer After Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771470
• Other study ID #: 2014SDU-QILU-G06
• Status: Completed
• Phase: Phase 1
• First received: July 14, 2015
• Last updated: May 21, 2017
• Start date: September 2014
• Est. completion date: July 2016

Study information

• Verified date: May 2017
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Effects of Chemotherapy
• Lung Cancer
• Lung Neoplasms
• Malnutrition
• Tumor Immunity

Intervention

Drug:
• Probiotics
Microbial composition using probiotic
• placebo
Microbiota modulation using placebo

Locations

Country	Name	City	State
China	Department of Gastroenterology,Qilu Hospital,Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 months
Secondary	Frequency and severity of Adverse effects during Chemotherapy		2 months
Secondary	The change of immunity and nutrition index		2 months