Liu Christine K, Seo Janet, Pravodelov Vassiliki, Frazier Susan, Guy Marsha, Concilio Katherine, Lau-Ng Rossana, Brandeis Gary, Watson Jon, van der Velde Jeannette, Olesen Scott W, Budree Shrish, Njenga Mary, Kassam Zain, Osman Majdi
Section of Geriatrics, Department of Medicine, Boston University School of Medicine and Boston Medical Center, Boston, MA, USA.
Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.
Contemp Clin Trials Commun. 2022 Mar 7;27:100906. doi: 10.1016/j.conctc.2022.100906. eCollection 2022 Jun.
INTRODUCTION: Antibiotic resistant bacterial infections (ARBIs) are extremely common in nursing home residents. These infections typically occur after a course of antibiotics, which eradicate both pathological and beneficial organisms. The eradication of beneficial organisms likely facilitates subsequent ARBIs. Autologous fecal microbiota transplant (aFMT) has been proposed as a potential treatment to reduce ARBIs in nursing home residents. Our objective was to determine the feasibility and safety of aFMT in a nursing home population. METHODS: Pilot clinical trial. We evaluated feasibility as total number of stool samples collected for aFMT production and safety as the number and relatedness of serious (SAE) and non-serious adverse events (AE). RESULTS: We screened 468 nursing home residents aged ≥18 years for eligibility; 67 enrolled, distributed among three nursing homes. Participants were 62.7% female and 35.8% Black. Mean age was 82.2 ± 8.5 years. Thirty-three participants underwent successful stool collection. Seven participants received antibiotics; four participants underwent aFMT. There were 40 SAEs (17 deaths) and 11 AEs. In the aFMT group, there were 3 SAEs (2 deaths) and 10 AEs. All SAEs and AEs were judged unrelated to the study intervention. CONCLUSIONS: In this pilot study of aFMT in nursing home residents, less than half were able to provide adequate stool samples for aFMT. There were no related SAEs or AEs during the study. In sum, we conclude aFMT has limited feasibility in a nursing home population due to logistic and technical challenges but is likely safe. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03061097.
引言:抗生素耐药性细菌感染(ARBIs)在疗养院居民中极为常见。这些感染通常在使用一个疗程的抗生素后发生,抗生素会根除致病生物和有益生物。有益生物的根除可能会促使随后发生ARBIs。自体粪便微生物群移植(aFMT)已被提议作为减少疗养院居民ARBIs的一种潜在治疗方法。我们的目的是确定aFMT在疗养院人群中的可行性和安全性。 方法:试点临床试验。我们将收集用于aFMT制备的粪便样本总数评估为可行性,将严重不良事件(SAE)和非严重不良事件(AE)的数量及相关性评估为安全性。 结果:我们对468名年龄≥18岁的疗养院居民进行了资格筛查;67人入选,分布在三家疗养院。参与者中62.7%为女性,35.8%为黑人。平均年龄为82.2±8.5岁。33名参与者成功采集了粪便。7名参与者接受了抗生素治疗;4名参与者接受了aFMT。有40例SAE(17例死亡)和11例AE。在aFMT组,有3例SAE(2例死亡)和10例AE。所有SAE和AE均被判定与研究干预无关。 结论:在这项针对疗养院居民的aFMT试点研究中,不到一半的人能够提供足够的粪便样本用于aFMT。研究期间没有相关的SAE或AE。总之,我们得出结论,由于后勤和技术挑战,aFMT在疗养院人群中的可行性有限,但可能是安全的。 试验注册:ClinicalTrials.gov标识符:NCT03061097。
Contemp Clin Trials Commun. 2022-3-7
Gastroenterology. 2021-1
Contemp Clin Trials Commun. 2017-12-21
Am J Gastroenterol. 2014-6-3
Front Cell Infect Microbiol. 2021
J Infect Dis. 2021-6-16