Radiation induced enteropathy is a common complication of radiotherapy for pelvic tumors and adversely affects patient quality of life. Probiotics are thought to restore bowel microflora to optimal levels and reinforce intestinal barrier capacity. Although probiotics are effective in the treatment of radiation induced enteropathy, less is known about their efficacy to prevent radiation induced enteropathy. This double-blind randomized placebo-controlled study will investigate the efficacy of probiotics to prevent radiation-induced enteropathy in patients with gynecologic or urologic cancer who received pelvic radiotherapy. The study is designed to enroll 248 eligible patients, who will be randomized 1:1 to a probiotic or placebo group. Toxicities will be evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The primary aim of this study is to provide high level evidence for the ability of probiotics to prevent acute radiation induced enteropathy. The secondary aims are to determine the effects of probiotics on the incidence of chronic radiation induced enteropathy and the safety of probiotics in patients with gynecologic or urologic cancer. ClinicalTrials.gov ( NCT03978949 , Registered on 7 June 2019).

中文翻译：

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益生菌预防放疗引起的肠病（PREP）：双盲随机安慰剂对照试验方案


放射诱发的肠病是盆腔肿瘤放射治疗的常见并发症，对患者的生活质量产生不利影响。益生菌被认为可以将肠道微生物群恢复到最佳水平并增强肠道屏障能力。尽管益生菌可有效治疗放射性肠病，但对其预防放射性肠病的功效知之甚少。这项双盲随机安慰剂对照研究将调查益生菌预防接受盆腔放疗的妇科或泌尿系统癌症患者放射性肠病的功效。该研究旨在招募 248 名符合条件的患者，他们将按照 1:1 的比例随机分配到益生菌组或安慰剂组。将使用不良事件通用术语标准 (CTCAE) v5.0 评估毒性。这项研究的主要目的是为益生菌预防急性放射性肠病的能力提供高水平的证据。次要目的是确定益生菌对慢性放射性肠病发病率的影响以及益生菌对妇科或泌尿系统癌症患者的安全性。 ClinicalTrials.gov（NCT03978949，注册于 2019 年 6 月 7 日）。