Faculty of Medicine, Department of Pediatric Gastroenterology, Hepatology and Nutrition, Bulent Ecevit University, Zonguldak, Turkey.
Faculty of Medicine, Department of Pediatrics, Bulent Ecevit University, Zonguldak, Turkey.
Can J Gastroenterol Hepatol. 2017;2017:8130596. doi: 10.1155/2017/8130596. Epub 2017 Jun 1.
The aim of this study is to evaluate the effects of the synbiotic B94 plus inulin addition to the standard triple therapy on infection eradication rates.
Children aged 6-16 years who had biopsy proven infection were randomly classified into two groups. The first group received the standard triple therapy consisting of amoxicillin + clarithromycin + omeprazole. The second group was treated with the standard triple therapy and B94 (5 × 10 CFU/dose) plus inulin (900 mg) for 14 days, concurrently. Eradication was determined by C-urea breath test 4-6 weeks after therapy discontinuation.
From a total of 69 infected children (F/M = 36/33; mean ± SD = 11.2 ± 3.0 years), eradication was achieved in 20/34 participants in the standard therapy group and 27/35 participants in the synbiotic group. The eradication rates were not significantly different between the standard therapy and the synbiotic groups [intent-to-treat, 58.8% and 77.1%, resp., = 0.16; per-protocol, 64.5% and 81.8%, resp., = 0.19]. There was no difference between the groups in terms of symptom relief ( = 0.193). The reported side effects were ignorable.
Considering the eradication rates, synbiotic addition to therapy showed no superiority over the standard triple therapy conducted alone. This trial is registered with NCT03165253.
本研究旨在评估在标准三联疗法基础上加用合生元 B94 加菊粉对根除率的影响。
对经活检证实存在幽门螺杆菌感染的 6-16 岁儿童进行随机分组。第一组接受包含阿莫西林+克拉霉素+奥美拉唑的标准三联疗法。第二组接受标准三联疗法加 B94（5×10CFU/剂量）和菊粉（900mg），疗程为 14 天。停药后 4-6 周通过 C-尿素呼气试验确定根除情况。
共有 69 例幽门螺杆菌感染儿童（F/M=36/33；平均±标准差=11.2±3.0 岁），标准治疗组 20/34 例和合生元组 27/35 例患者根除。标准治疗组和合生元组的根除率无显著差异[意向治疗，58.8%和 77.1%，=0.16；符合方案集，64.5%和 81.8%，=0.19]。两组在症状缓解方面无差异（=0.193）。报告的副作用可以忽略不计。
考虑到根除率，合生元联合治疗并不优于单独的标准三联疗法。本试验已在 NCT03165253 注册。
