Yoon Jin Young, Cha Jae Myung, Hong Seong Soo, Kim Hyung Kyung, Kwak Min Seob, Jeon Jung Won, Shin Hyun Phil
Department of Internal Medicine, Division of Gastroenterology, Kyung Hee University Hospital at Gang Dong, Kyung Hee University School of Medicine.
Division of Gastroenterology, Vievis Namuh Hospital.
Medicine (Baltimore). 2019 Aug;98(35):e16601. doi: 10.1097/MD.0000000000016601.
Lactobacillus paracasei and Glycyrrhiza glabra have been reported as having beneficial effects on Helicobacter pylori infection. We aimed to assess the efficacy and safety of fermented milk containing L paracasei HP7 and G glabra in patients with H pylori infection.
This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted in 2 hospitals from April to December 2017. Patients with H pylori infection were randomized into either the treatment group (fermented milk with L paracasei HP7 and G glabra) or placebo group (fermented milk only) once daily for 8 weeks. The primary endpoint was the gastric load of H pylori measured by C-urea breath test (UBT). Secondary endpoints were histologic and clinical improvement.
A total of 142 patients were randomly allocated to the treatment (n = 71) or placebo groups (n = 71). Compared to baseline data, the quantitative value of C-UBT at 8 weeks was significantly reduced in the treatment group (from 20.8 ± 13.2% to 16.9 ± 10.8%, P = .035), but not in the placebo group (P = .130). Chronic inflammation improved significantly only in the treatment group (P = .013), whereas the neutrophil activity deteriorated significantly only in the placebo group (P = .003). Moreover, the treatment group had significant improvement in gastrointestinal symptoms (P = .049) and quality of life (P = .029). No serious adverse events were observed.
The combination of fermented milk containing L paracasei and G glabra reduced H pylori density and improved histologic inflammation. However, their mechanisms of action should be elucidated in further studies.
据报道,副干酪乳杆菌和光果甘草对幽门螺杆菌感染具有有益作用。我们旨在评估含副干酪乳杆菌HP7和光果甘草的发酵乳对幽门螺杆菌感染患者的疗效和安全性。
这项多中心、前瞻性、随机、双盲、安慰剂对照临床试验于2017年4月至12月在2家医院进行。幽门螺杆菌感染患者被随机分为治疗组(含副干酪乳杆菌HP7和光果甘草的发酵乳)或安慰剂组(仅发酵乳),每天服用1次,共8周。主要终点是通过C-尿素呼气试验(UBT)测量的幽门螺杆菌胃负荷。次要终点是组织学和临床改善情况。
共有142例患者被随机分配到治疗组(n = 71)或安慰剂组(n = 71)。与基线数据相比,治疗组8周时C-UBT的定量值显著降低(从20.8±13.2%降至16.9±10.8%,P = 0.035),而安慰剂组未降低(P = 0.130)。仅治疗组的慢性炎症有显著改善(P = 0.013),而仅安慰剂组的中性粒细胞活性显著恶化(P = 0.003)。此外,治疗组的胃肠道症状(P = 0.049)和生活质量(P = 0.029)有显著改善。未观察到严重不良事件。
含副干酪乳杆菌和光果甘草的发酵乳组合可降低幽门螺杆菌密度并改善组织学炎症。然而,其作用机制应在进一步研究中阐明。