Oral Probiotics on Radiation Enteritis Stage Ⅱ Induced by Pelvic Concurrent Chemoradiotherapy (probiotics)

A Randomized Controlled Clinical Study of Oral Probiotics on Radiation Enteritis Stage Ⅱ Induced by Pelvic Concurrent Chemoradiotherapy

Radiation-induced enteritis is an common and severe side effect of the patients undergoing pelvic radiotherapy. It can lead to dose-limiting and debilitating treatment effect. There is no guideline on an acknowledged intervention that significantly reduces its severity. In previous study, we have abserved that a probiotic combination significantly enhances the immune response of patients and reduces the severity of oral mucositis through modification of gut microbiota. In this stuyd we plan to designe a randomized trial of Probiotics probiotics in patients with pelvic carcinoma.The aim of this study is to determine if regulating intestinal tract flora will reduce the severity of radiation-induced mucositis in patients receiving pelvic radiotherapy. The effect of this intervention on a patient's general well-being was also investigated. The primary end-point of the study was the incidence of grade 3 enteritis. In 2021, 40 patients are estimated to be recruited into the study in Jiangxi Cancer Hospitals, China. 20 patients were randomized to receive Probiotics or placebo during chemoradiotherapy respectively.

The random assignment of patients was performed by Nanchang Medical University with a computer-generated random number code. Patients were randomly distributed in a 1:1 ratio to receive probiotics or a placebo (the block size was known only to the statistician). The drug was distributed and packaged in accordance with random numbers, and the documents stating the parameters, such as the blinding codes for the seeds of the random numbers, the block length, and the random numbers, were sealed in envelopes

Probiotic( recieving Probiotic at the first day of chemoradiotherapy daily)with radiotherapy and Chemotherapy Intervention

Inclusion Criteria: Karnofsky score ≥80 pelvic tumor patients receiving chemoradiotherapy in our Cancer Center Exclusion Criteria: any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease or drug allergy to Probiotics