Gegen Qinlian Tang and Probiotics for Radiation Enteritis

NCT06836960

The purpose of this clinical study is to evaluate whether Bifidobacterium Triple Viable Capsules, alone or in combination with Gegen Qinlian Decoction, can effectively prevent and treat acute radiation enteritis in patients undergoing abdominal or pelvic radiotherapy. The study aims to answer the following question: Can probiotics, with or without the addition of herbal medicine, reduce the incidence and severity of radiation-induced intestinal injury and improve the quality of life for patients during and after radiotherapy? A total of 60 patients with malignant tumors receiving abdominal or pelvic radiotherapy will be recruited and randomly assigned to one of three groups: a control group (no intervention), a probiotics-only group (Bifidobacterium Triple Viable Capsules, three capsules twice daily), and a combination therapy group (probiotics with modified Gegen Qinlian Decoction tailored to individual symptoms). The primary outcome will be the incidence and severity of acute radiation enteritis, assessed using the RTOG/EORTC grading criteria (0-IV levels). Daily observations will be recorded during radiotherapy, with follow-up lasting three months after the completion of treatment. This study seeks to provide evidence for the use of probiotics and herbal medicine as effective strategies to mitigate the side effects of radiotherapy and improve patient outcomes.