The purpose of this study is to evaluate the effect of probiotics to improve the 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
26
Effects of probiotics supplementation on intestinal microbiome; 2capsule bid orally for six weeks, 1capsule(500mg) Started eating probiotics one week prior of radiation therapy.
Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.
Seoul National University Hospital
Seoul, South Korea
RECRUITINGChanges 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.
Time frame: 42 days
Prevention of any grade of diarrhea and gastrointestinal symptoms
* Gastrointestinal symptoms will be scored according the Gastrointestinal symptom rating scale before and after RTx. * Diarrhea will be graded weekly according the Common Toxicity Criteria system.
Time frame: 42 days
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