Dept. of Medical Gastroenterology, Hvidovre Hospital, University Hospital of Copenhagen, Denmark.
J Crohns Colitis. 2011 Apr;5(2):115-21. doi: 10.1016/j.crohns.2010.11.004. Epub 2011 Jan 8.
To investigate the clinical effect of treatment with Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis BB-12 (Probio-Tec AB-25) to maintain remission in patients with ulcerative colitis.
Patients with left-sided ulcerative colitis in remission - including proctitis and at least one relapse within the last year were randomised (2:1) in a double-blind placebo-controlled study to Probio-Tec AB-25 or placebo for 52 weeks. The patients were evaluated clinically, endoscopically and histologically at entry and if relapsing. No other medication for ulcerative colitis than the study drug was allowed during the study. Primary endpoint was maintenance of clinical remission, secondary endpoints comparisons of days to relapse, and safety and tolerability of the study drug. The concentrations of the probiotic bacterial strains in stool were analysed in a subset of patients.
Thirty-two patients were randomised. Twenty patients received Probio-Tec AB-25 and twelve patients received placebo. Five patients (25%) in the Probio-Tec AB-25 group and one patient (8%) in the placebo group maintained remission after 1 year of treatment (p=0.37). The median time to relapse was 125.5days (range 11-391 days) in the probiotic group and 104 days (range 28-369 days) in the placebo group respectively, (p=0.683). Probio-Tec AB-25 was overall well tolerated.
In this small randomised placebo-controlled trial no significant clinical benefit of Probio-Tec AB-25 could be demonstrated in comparison with placebo for maintaining remission in patients with left-sided ulcerative colitis. A difference may be achieved in larger studies, but the clinical significance of this would be questionable. This study was registered in ClinicalTrial.gov (NCT00268164).
研究嗜酸乳杆菌 La-5 和动物双歧杆菌亚种乳双歧杆菌 BB-12（Probio-Tec AB-25）治疗对溃疡性结肠炎缓解患者维持缓解的临床效果。
患有左半结肠炎缓解期（包括直肠炎和过去一年中至少有一次复发）的患者，按 2:1 的比例在一项双盲安慰剂对照研究中随机分为 Probio-Tec AB-25 或安慰剂组，进行 52 周的治疗。在入组时和复发时，对患者进行临床、内镜和组织学评估。研究期间，除研究药物外，不允许使用其他治疗溃疡性结肠炎的药物。主要终点是维持临床缓解，次要终点是比较复发天数，以及研究药物的安全性和耐受性。对部分患者的粪便中益生菌菌株的浓度进行了分析。
32 名患者被随机分组。20 名患者接受 Probio-Tec AB-25 治疗，12 名患者接受安慰剂治疗。在 Probio-Tec AB-25 组中，有 5 名患者（25%）和安慰剂组中 1 名患者（8%）在治疗 1 年后维持缓解（p=0.37）。益生菌组的中位复发时间为 125.5 天（范围 11-391 天），安慰剂组为 104 天（范围 28-369 天），（p=0.683）。Probio-Tec AB-25 总体上耐受良好。
在这项小型随机安慰剂对照试验中，与安慰剂相比，Probio-Tec AB-25 对维持左半结肠炎患者的缓解没有显著的临床益处。在更大的研究中可能会取得差异，但这在临床上的意义值得怀疑。这项研究在 ClinicalTrials.gov（NCT00268164）注册。
