Pilot study on the safety and efficacy of ciprofloxacin for prophylactic preventi

描述（由申请人提供）：尽管进行了广泛的医学治疗，但在某些时候，约70%-80%的患者需要手术切除。然而，绝大多数患者术后复发，这是手术治疗的严重局限性。在这种情况下，细菌植物群起着重要的作用，如术后甲硝唑或奥硝唑抗生素治疗的益处或回肠造口术患者无炎症所证明的。然而，上述两种抗生素方案都有许多不良事件，限制了这种疗法在日常临床实践中的价值。环丙沙星抑制革兰氏阴性需氧菌，包括肠粘附性/侵袭性大肠杆菌。大肠杆菌菌株，其在克罗恩病患者的早期和慢性回肠病变中增加。有限数量的临床数据表明，这种药物在确诊克罗恩病患者中的疗效。这项探索性多中心前瞻性、安慰剂对照试验在9家经验丰富的IBD中心进行，将在40例接受回盲部切除术和一期吻合术的患者（以1：1的比例随机分配）中分析环丙沙星与安慰剂治疗6个月的安全性和耐受性。不允许对克罗恩病进行其他治疗。本研究的主要目的是评估环丙沙星（500 mg bid）与安慰剂片剂治疗6个月预防术后克罗恩病患者内镜下复发的安全性和耐受性。本研究的次要目的是评价新末端回肠和回结肠吻合处的内镜复发率以及结肠病变的程度。此外，还将采集吻合部位的活检样本和患者DNA和血清学样本，用于随后的细菌核糖体16 S DNA、细菌抗体和DNA多态性（如NOD 2、OCTN/1/2、ATG 16 L1或IL-23受体）分析。本研究产生的临床数据将作为确定性临床试验的基础，研究环丙沙星在预防克罗恩病术后内镜复发中的有效性。

DESCRIPTION (provided by applicant): Despite extensive medical treatment, surgical resection is required in approximately 70%-80% of the patients at some time. However, recurrence of the disease after operation occurs in the vast majority of patients and is a serious limitation of surgical management. In this setting the bacterial flora plays an important role as demonstrated by the benefit of postoperative antibiotic therapy with either metronidazole or ornidazole or the absence of inflammation in patients with diverting ileostomy. However, both aforementioned antibiotic regimens have numerous adverse events limiting the value of this therapy in daily clinical practice. Ciprofloxacin suppresses Gram negative aerobic bacterial species, including enteroadherent/invasive E. coli strains, which are increased in early and chronic ileal lesions of Crohn's disease patients. A limited number of clinical data suggest efficacy of this drug in patients with established Crohn's disease. This exploratory multicenter prospective, placebo-controlled trial performed at 9 experienced IBD centers will analyze the safety and tolerability of a 6 months therapy with ciprofloxacin compared to placebo in 40 patients (randomly assigned in a 1:1 ratio) undergoing ileocecal resection with primary anastomosis. No other treatments for Crohn's disease will be permitted. The primary objective of this study is to assess the safety and tolerability of 6 months therapy of ciprofloxacin (500 mg bid) vs. placebo tablets for prevention of endoscopic recurrence in postoperative Crohn's disease patients. The secondary objectives of this study are to evaluate the rate of endoscopic recurrence in the neoterminal ileum and at the ileocolonic anastomosis as well as the extent of colonic lesions. Additionally biopsy samples at the anastomotic site and patient DNA and serology samples will be collected for later analysis of bacterial ribosomal 16S DNA, bacterial antibodies and DNA polymorphisms (such as NOD2, OCTN/1/2, ATG 16L1 or IL-23 receptor). The clinical data generated by this study will serve as a basis for a definitive clinical trial investigating the effectiveness of ciprofloxacin in the prevention of endoscopic recurrence in postoperative Crohn's disease.