Intestinal Microflora in Lung Cancer After Chemotherapy

Shandong University

Status and phase: Completed; Phase 1

Conditions: Malnutrition; Tumor Immunity; Lung Cancer; Effects of Chemotherapy

Treatments: Drug: Probiotics; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02771470

2014SDU-QILU-G06

Details and patient eligibility

About

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

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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41 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

Microbial composition using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks

Treatment:

Drug: Probiotics

Placebo

Placebo Comparator group

Description:

Microbiota modulation using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks

Treatment:

Drug: placebo