Doron Shira, Hibberd Patricia L, Goldin Barry, Thorpe Cheleste, McDermott Laura, Snydman David R
Division of Infectious Diseases, Tufts Medical Center, Boston, Massachusetts, USA
Division of Global Health, Massachusetts General Hospital, Boston, Massachusetts, USA.
Antimicrob Agents Chemother. 2015 Aug;59(8):4593-9. doi: 10.1128/AAC.00300-15. Epub 2015 May 26.
Vancomycin-resistant enterococci (VRE) are endemic in health care settings. These organisms colonize the gastrointestinal tract and can lead to infection which is associated with increased mortality. There is no treatment for VRE colonization. We conducted a randomized, double-blind, placebo-controlled clinical trial to examine the safety and efficacy of administration of the probiotic Lactobacillus rhamnosus GG (LGG) for the reduction or elimination of intestinal colonization by VRE. Colonized adults were randomized to receive LGG or placebo for 14 days. Quantitative stool cultures for LGG and VRE were collected at baseline and days 7, 14, 21, 28, and 56. Day 14 stool samples from some subjects were analyzed by quantitative PCR (qPCR) for LGG. Patients were closely monitored for adverse events. Eleven subjects, of whom 5 received LGG and 6 received placebo, were analyzed. No differences in VRE colony counts were seen at any time points between groups. No decline in colony counts was seen over time in subjects who received LGG. LGG was detected by PCR in all samples tested from subjects who received LGG but was only isolated in culture from 2 of 5 subjects in the LGG group. No treatment-related adverse events were seen. We demonstrated that LGG could be administered safely to patients with comorbidities and is recoverable in some patients' stool cultures. Concomitant administration of antibiotics may have resulted in an inability to recover viable organisms from stool samples, but LGG DNA could still be detected by qPCR. LGG administration did not affect VRE colonization in this study. (This study was registered at Clinicaltrials.gov under registration no. NCT00756262.).
耐万古霉素肠球菌(VRE)在医疗机构中呈地方性流行。这些微生物定殖于胃肠道,可导致感染,而感染与死亡率增加相关。VRE定殖尚无治疗方法。我们进行了一项随机、双盲、安慰剂对照临床试验,以检验给予益生菌鼠李糖乳杆菌GG(LGG)减少或消除VRE肠道定殖的安全性和有效性。定殖的成年人被随机分配接受LGG或安慰剂治疗14天。在基线以及第7、14、21、28和56天收集LGG和VRE的定量粪便培养物。对部分受试者第14天的粪便样本进行LGG定量聚合酶链反应(qPCR)分析。密切监测患者的不良事件。对11名受试者进行了分析,其中5人接受LGG,6人接受安慰剂。两组在任何时间点的VRE菌落计数均无差异。接受LGG的受试者菌落计数未随时间下降。在接受LGG的受试者检测的所有样本中,通过PCR均检测到LGG,但LGG组仅5名受试者中的2人粪便培养物中分离出LGG。未观察到与治疗相关的不良事件。我们证明LGG可安全给予合并症患者,且在部分患者的粪便培养物中可恢复。同时使用抗生素可能导致无法从粪便样本中恢复活的微生物,但仍可通过qPCR检测到LGG DNA。本研究中给予LGG不影响VRE定殖。(本研究已在Clinicaltrials.gov注册,注册号为NCT00756262。)