Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Pts(Get Pelvic/Abdominal Rtx) (RTxIMprobio)
Recruitment status was: Recruiting
|Cancer||Dietary Supplement: probiotics (six probiotic cultures) Dietary Supplement: Placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
|Official Title:||Double Blind Placebo Controled Randomized Trial, Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Patients Who Get Pelvic/Abdominal Radiotherapy|
- Changes of gut microbial communities in malignancy patients receiving pelvic/abdominal radiotherapy after probiotics administration to prevent radiation enteropathy. [ Time Frame: 42 days ]
- 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.
- Prevention of any grade of diarrhea and gastrointestinal symptoms [ Time Frame: 42 days ]
- 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.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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)
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 Comparator: placebo
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
Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706393
|Contact: Hak Jae Kim, MDfirstname.lastname@example.org|
|Contact: Seung Wan Kang, MD,PhDemail@example.com|
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Hak Jae Kim, MD||Seoul National University Hospital|