Tucker Emily C, Haylock-Jacobs Sarah, Rapaic Mirjana, Dann Lisa M, Bryant Robert V, Costello Samuel P
BiomeBank Thebarton South Australia Australia.
Department of Infectious Diseases Flinders Medical Centre Bedford Park South Australia Australia.
JGH Open. 2023 Feb 21;7(3):172-177. doi: 10.1002/jgh3.12874. eCollection 2023 Mar.
This study evaluates whether a stool donor program to supply fecal microbiota transplantation (FMT) product is feasible in the Australian regulatory environment. The primary outcome was capacity to supply FMT product. The secondary outcomes were donor eligibility, retention, and output.
Prospective observational cohort study using data collected from the stool donor and FMT production records from BiomeBank, South Australia. Participants were people who engaged with BiomeBank's donor screening and FMT manufacturing process between 01 January 2021 and 31 December 2021.
In total 176 people registered interest in the program, 74 of 176 (42.0%) proceeded to written questionnaire, 14 of 176 (8.0%) underwent clinical assessment, and 8 of 176 (4.5%) enrolled in the program. Two people were ineligible based on laboratory tests: both had an extended spectrum beta-lactamase producing organism in stool and one also tested positive for hepatitis B core antibody. Two donors remained eligible from 2020, resulting in 10 enrolled donors in 2021; 5 of 10 (50%) male with a median age of 36.9 years (interquartile range, 30.3-42.7 years). All donors were ineligible to donate at some time point. There were 144 stool donations processed into 1480 50 mL FMT; 413 FMT were shipped to 33 Australian hospitals for treatment, 470 for clinical trials, and 89 were destroyed prior to release from quarantine.
Recruitment into the program, retention, and maximizing the yield from a donation period was challenging. Despite this, BiomeBank was able to produce and supply FMT to Australian hospitals under the TGA-regulated Class 2 Biologicals framework.
本研究评估在澳大利亚监管环境下，粪便供体计划供应粪便微生物群移植（FMT）产品是否可行。主要结果是供应FMT产品的能力。次要结果是供体资格、留存率和产量。
采用前瞻性观察队列研究，收集来自南澳大利亚生物银行的粪便供体数据和FMT生产记录。参与者为2021年1月1日至2021年12月31日期间参与生物银行供体筛查和FMT制造过程的人员。
共有176人对该计划表示感兴趣，176人中74人（42.0%）进入书面问卷调查，176人中14人（8.0%）接受临床评估，176人中8人（4.5%）加入该计划。根据实验室检测，有两人不符合资格：两人粪便中均有产超广谱β-内酰胺酶的生物体，其中一人乙肝核心抗体检测也呈阳性。2020年有两名供体仍符合资格，因此2021年有10名登记供体；10名中有5名（50%）为男性，中位年龄为36.9岁（四分位间距，30.3 - 42.7岁）。所有供体在某些时间点均不符合捐赠条件。共处理了144次粪便捐赠，制成1480份50毫升的FMT；413份FMT被运往33家澳大利亚医院用于治疗，470份用于临床试验，89份在解除隔离前被销毁。
该计划的招募、留存以及在捐赠期内实现产量最大化具有挑战性。尽管如此，生物银行能够在澳大利亚治疗用品管理局（TGA）监管的2类生物制品框架下生产并向澳大利亚医院供应FMT。
