The major reservoir of carbapenemase-producing Enterobacteriaceae (CPE) is the gastrointestinal tract of colonized patients. Colonization is silent and may last for months, but the risk of infection by CPE in colonized patients is significant. Eight long-term intestinal carriers of OXA-48-producing Enterobacteriaceae (OXA-PE) were treated during 3 weeks with daily oral lactitol (Emportal®), Bifidobacterium bifidum and Lactobacillus acidophilus (Infloran®). Weekly stool samples were collected during the treatment period and 6 weeks later. The presence of OXA-PE was investigated by microbiological cultures and qPCR. At the end of treatment (EoT, secondary endpoint 1), four of the subjects had negative OXA-PE cultures. Three weeks later (secondary endpoint 2), six subjects were negative. Six weeks after the EoT (primary endpoint), three subjects had negative OXA-PE cultures. The relative intestinal load of OXA-PE decreased in all the patients during treatment. The combination of prebiotics and probiotics was well tolerated. A rapid reduction on the OXA-PE intestinal loads was observed. At the EoT, decolonization was achieved in three patients. Clinical Trials Registration: NCT02307383. EudraCT Number: 2014-000449-65.

中文翻译：

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乳糖醇与双歧双歧杆菌和嗜酸乳杆菌联合用于根除肠道产生 OXA-48 的肠杆菌科的概念验证试验

产碳青霉烯酶肠杆菌科（CPE）的主要宿主是定植患者的胃肠道。定植是无声的，可能持续数月，但定植患者感染 CPE 的风险很大。八名产生 OXA-48 的肠杆菌科细菌 (OXA-PE) 的长期肠道携带者在 3 周内接受了每日口服乳糖醇 (Emportal®)、双歧杆菌和嗜酸乳杆菌 (Infloran®) 的治疗。在治疗期间和 6 周后每周收集粪便样本。通过微生物培养和 qPCR 研究了 OXA-PE 的存在。在治疗结束时（EoT，次要终点 1），四名受试者的 OXA-PE 培养物呈阴性。三周后（次要终点 2），六名受试者为阴性。EoT（主要终点）后六周，三名受试者的OXA-PE培养阴性。治疗期间所有患者OXA-PE的相对肠道负荷均降低。益生元和益生菌的组合耐受性良好。观察到 OXA-PE 肠道负荷迅速降低。在 EoT，三名患者实现了非定植。临床试验注册：NCT02307383。EudraCT 编号：2014-000449-65。