An interventional study of probiotics (six probiotic cultures) and Placebo in Cancer, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-04-19.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Basic science
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 26 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Exclusion Criteria:
Probiotics supplementation group. Probiotics intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day. Probiotics is composed of Lactobacillus acidophilus, Streptococcus thermophilus, Bifidobacterium lactis, L. rhamnosus, B. longum and B. bifidum.
Dietary Supplement: probiotics (six probiotic cultures)
Placebo group. Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day. Placebo is composed of starch.Probiotics and placebo were similar in appearance, taste.
Dietary Supplement: Placebo
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.
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.
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
This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital