Double Blind Placebo Controled Randomized Trial, Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Patients Who Get Pelvic/Abdominal Radiotherapy
Pelvic/abdominal radiotherapy carries a risk of complications. Acute complications include
diarrhea, abdominal pain, inflammatory change in the small intestine. Radiation creates
changes in bacterial microbiome, the vascular permeability of the mucosal cells and in
intestinal motility. Probiotics were known to improve gastrointestinal function. This is a
randomized, double-blind, placebo-controlled study involving 26 patients designed to
evaluate the effect of probiotics to change the intestinal microbiome in in patients
undergoing concurrent pelvic/abdominal RT.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science
Changes of gut microbial communities in malignancy patients receiving pelvic/abdominal radiotherapy after probiotics administration to prevent radiation enteropathy.
Comparison of overall microbial communities in fecal samples between probiotics treated patients and control cancer patients receiving radiation therapy. To determine preventing effect of probiotics against radiation enteropathy, all the bacterial species level taxon derived from fecal samples of cancer patients will be identified by massive sequencing analysis and relative abundance of each taxon between two groups will be statistically compared. In addition, overall microbial composition, kind of species and their abundance, in two groups will be compared with clustering method such as UPGMA and PCoA and the variation values between two groups will be calculated. In the current study, we will determine the effectiveness of probiotics for the prevention of radiation induced complications with these two comparative analysis methods.
Hak Jae Kim, MD
Seoul National University Hospital
South Korea: Institutional Review Board