Double Blind Placebo Controled Randomized Trial, Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Patients Who Get Pelvic/Abdominal Radiotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Changes of gut microbial communities in malignancy patients receiving pelvic/abdominal radiotherapy after probiotics administration to prevent radiation enteropathy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who current diagnosis of gynecologic cancer or rectal cancer and never previously received radiation therapy and will use for the first time radiotherapy at department of radiation oncology, Seoul National University Hospital.
- •ECOG performance status (PS) of 0, 1, or
- •signed written informed consent.
- •Patients who get pelvic/abdominal radiotherapy.
排除标准
- •People who use antibiotics that can affect intestinal microorganism growth within one month before the study.
- •Patients who use probiotics within one month before the study.
- •Patients received neoadjuvant chemotherapy.
- •Acute enteritis symptoms (diarrhea, abdominal pain, nausea, vomiting) for the patient.
- •Patients diagnosed with inflammatory bowel disease.
- •Patients suspected gastrointestinal infections and other infectious diseases.
- •Suspected infections from blood tests : Excessive rise in WBC, ESR, CRP
- •Suspected renal insufficiency from blood tests
结局指标
主要结局
Changes of gut microbial communities in malignancy patients receiving pelvic/abdominal radiotherapy after probiotics administration to prevent radiation enteropathy.
时间窗: 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.
次要结局
- Prevention of any grade of diarrhea and gastrointestinal symptoms(42 days)