Intestinal Microflora in Lung Cancer After Chemotherapy

Phase 1

Completed

• Conditions: Lung Cancer; Effects of Chemotherapy; Tumor Immunity; Malnutrition
• Interventions: Drug: Probiotics; Drug: placebo

• Registration Number: NCT02771470
• Lead Sponsor: Shandong University

Brief Summary

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

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-13
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-21
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotics	Microbial composition using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks
Placebo	placebo	Microbiota modulation using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Frequency and severity of Adverse effects during Chemotherapy	2 months
The change of immunity and nutrition index	2 months

Trial Locations

Locations (1)

Department of Gastroenterology,Qilu Hospital,Shandong University; 🇨🇳 Jinan, Shandong, China