| Yang Yinyin,Hu Yijia,Gu Xuhao,et al.Preventive effects of Bifidobacterium longum subsp. longum BL21 on acute radiation-induced diarrhea during radiotherapy for cervical cancer: A single-arm, phase Ⅱ trial[J].Chinese Journal of Radiological Medicine and Protection,2025,45(2):101-107 |
| Preventive effects of Bifidobacterium longum subsp. longum BL21 on acute radiation-induced diarrhea during radiotherapy for cervical cancer: A single-arm, phase Ⅱ trial |
| Received:November 13, 2024 |
| DOI：10.3760/cma.j.cn112271-20241113-00436 |
| KeyWords:Cervical cancer Radiation-induced diarrhea (RID) Bifidobacterium longum subsp. longum BL21 Gut microbiota |
| FundProject:江苏省卫生健康委员会科研项目-面上项目(M2021081);苏州市姑苏卫生人才计划人才科研项目(GSWS2021025);苏州大学临床医学教育家计划项目(MA12300123);苏州市放射肿瘤学临床医学中心(Szlcyxzx202103),肿瘤治疗学省医学重点学科建设单位(JSDW202236) |
| Author Name | Affiliation | E-mail | | Yang Yinyin | Department of Radiotherapy and Oncology, Second Affiliated Hospital of Soochow University, Clinical Medical Center for Radiotherapy of Suzhou, Suzhou 215004, China | | | Hu Yijia | Department of Radiotherapy and Oncology, Second Affiliated Hospital of Soochow University, Clinical Medical Center for Radiotherapy of Suzhou, Suzhou 215004, China | | | Gu Xuhao | Department of Radiotherapy and Oncology, Second Affiliated Hospital of Soochow University, Clinical Medical Center for Radiotherapy of Suzhou, Suzhou 215004, China | | | Xia Tong | Department of Radiotherapy and Oncology, Second Affiliated Hospital of Soochow University, Clinical Medical Center for Radiotherapy of Suzhou, Suzhou 215004, China | | | Xu Ruizhe | Department of Radiotherapy and Oncology, Second Affiliated Hospital of Soochow University, Clinical Medical Center for Radiotherapy of Suzhou, Suzhou 215004, China | | | Liu Chang | Department of Radiotherapy and Oncology, Second Affiliated Hospital of Soochow University, Clinical Medical Center for Radiotherapy of Suzhou, Suzhou 215004, China | | | Zou Li | Department of Radiotherapy and Oncology, Second Affiliated Hospital of Soochow University, Clinical Medical Center for Radiotherapy of Suzhou, Suzhou 215004, China | li_zou@126.com | | Tian Ye | Department of Radiotherapy and Oncology, Second Affiliated Hospital of Soochow University, Clinical Medical Center for Radiotherapy of Suzhou, Suzhou 215004, China | |
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| Abstract:: |
| Objective To evaluate the safety and efficacy of the probiotic Bifidobacterium longum subsp. longum BL21 (BL21) in preventing radiation-induced diarrhea (RID) in cervical cancer patients during radiotherapy (RT) and to investigate the intestinal microbiota in the patients. Methods This study was a prospective, single-arm, phase Ⅱ clinical trial, involving cervical cancer patients treated with radical and adjuvant RT. From the first day of RT, participants took one pack of BL21 powder (containing 20 billion colony-forming unit(CFU) of Bifidobacterium longum subsp. longum BL21) orally every day until the end of RT. The occurrence of adverse events and RID during RT were assessed as per Common Terminology Criteria for Adverse Events (CTCAE) v5.0. In this way, the safety and efficacy of BL21 in preventing RID were evaluated. Additionally, the intestinal microbiota in fecal samples collected from the patients before and after RT were analyzed using 16S rRNA sequencing. Results A total of 35 cervical cancer patients were enrolled in this study, with 29 cases incorporated for the final analysis. No serious adverse event related to the administration of BL21 was observed. The patients exhibited slight RID, with the majority (22/29) developing no or grade 1 RID during RT. The microbiota in the fecal samples showed decreased alpha diversity after RT, as indicated by the Chao1 (P = 0.002) and Shannon (P = 0.005) indices. Furthermore, these samples exhibited a notably higher abundance of genus Clostridium (LDA score = 3.98). The fecal samples from patients with grade 1 RID or no RID post-RT exhibited higher alpha diversity than those from patients with grade 2 RID or above post-RT (Chao1: P = 0.07, Shannon: P = 0.28), as well as a high abundance of genera Gemmiger (LDA score = 4.48) and Dorea (LDA score = 3.83). Conclusions The administration of BL21 to cervical cancer patients during RT is simple, convenient, safe, and effective in preventing RID, thus warranting further investigation. |
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