Effects of Chemotherapy, Lung Cancer, Malnutrition, Tumor Immunity
Conditions
Keywords
Gut microflora, Lung cancer, Chemotherapy, Immunity, Nutrition
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.
Interventions
DRUGProbiotics
Microbial composition using probiotic
DRUGplacebo
Microbiota modulation using placebo
Sponsors
Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Frequency and severity of Adverse effects during Chemotherapy | 2 months |
| The change of immunity and nutrition index | 2 months |
Countries
China
Outcome results
None listed