Knapple Whitfield L, Yoho David S, Sheh Alexander, Thul Joan, Feuerstadt Paul
Arkansas Gastroenterology, 3401 Springhill Drive #400, North Little Rock, AR 72117, USA.
Mid-Atlantic Permanente Medical Group, Springfield, VA, USA.
Therap Adv Gastroenterol. 2024 Mar 24;17:17562848241239547. doi: 10.1177/17562848241239547. eCollection 2024.
Fecal microbiota, live-jslm (RBL; REBYOTA), is the first Food and Drug Administration (FDA)-approved, single-dose, rectally administered, microbiota-based live biotherapeutic product for preventing infection (CDI) recurrence. Alternative routes of administration are of clinical interest.
Evaluate the safety and efficacy of RBL administration colonoscopy.
Retrospective analysis of electronic medical records of participants administered RBL colonoscopy under FDA enforcement discretion.
The number of participants with treatment and/or procedure-emergent adverse events (TEAEs) was evaluated. Treatment success and sustained clinical response, defined as the absence of CDI recurrence within 8 weeks and 6 months, respectively, were evaluated.
TEAEs were experienced by 75% (6/8) of participants; most were mild to moderate in severity, and none due to RBL or its administration. Most participants had treatment success (80%; 8/10); 75% (6/8) had sustained clinical response.
Real-world safety and efficacy of RBL administered colonoscopy were consistent with clinical trials of rectally administered RBL.
粪便微生物群制剂，即活的艰难梭菌芽孢杆菌（RBL；商品名REBYOTA），是美国食品药品监督管理局（FDA）批准的首个用于预防艰难梭菌感染（CDI）复发的单剂量直肠给药的基于微生物群的活菌生物治疗产品。其他给药途径具有临床研究价值。
评估结肠镜检查时给予RBL的安全性和有效性。
对在FDA执法自由裁量权下接受结肠镜检查时给予RBL的参与者的电子病历进行回顾性分析。
评估出现治疗和/或操作相关不良事件（TEAE）的参与者数量。评估治疗成功率和持续临床反应，分别定义为8周和6个月内无CDI复发。
75%（6/8）的参与者出现TEAE；大多数为轻度至中度，且无一例是由RBL或其给药引起的。大多数参与者治疗成功（80%；8/10）；75%（6/8）有持续临床反应。
结肠镜检查时给予RBL的真实世界安全性和有效性与直肠给药RBL的临床试验一致。
