Baseline demographic data.

BackgroundFaecal microbiota transplantation (FMT) is recommended treatment for recurrent Clostridioides difficile infection and is studied as a potential modifier of other gastrointestinal and systemic disorders. Autologous FMT limits the potential risks of donor transplant material and enables prophylactic treatment. Capsulized FMT is convenient and accessible, but safety data are lacking.AimsTo describe safety and tolerability of capsules containing autologous FMT, compared to placebo, in healthy volunteers treated with antibiotics.MethodHealthy volunteers without antibiotic exposure during the past three months, that had a negative Clostridioides difficile stool sample, were recruited. Study persons donated faeces for production of capsules containing autologous microbiota. They were then given Clindamycin for seven days to disrupt the intestinal microbiota, which was followed by a two-day washout. Study persons were then randomized (1:1) to unsupervised treatment with autologous faecal matter or placebo, with two capsules twice daily for five days. A standardized questionnaire about side effects and tolerability, daily until day 28, and on days 60 and 180, was completed.ResultsTwenty-four study persons were included, all completed the treatment. One person from the placebo and FMT groups each, were lost to follow up from days 21 and 60, respectively. No study person experienced serious side effects, but severe fatigue was reported during the antibiotic period (n = 2). Reported side effects were mild to moderate and there were no significant differences between the groups. Reported general and intestinal health improved significantly and similarly in both groups after the antibiotic treatment. Time to normalized intestinal habits were 17 and 19 days from study start in the placebo group and the FMT group, respectively (p = 0.8).ConclusionCapsulized frozen autologous faecal microbiota transplantation was safe and well tolerated but did not affect time to normalized intestinal habits compared to placebo.Trial registrationEudraCT 2017-002418-30.研究背景：粪便微生物群移植（Fecal microbiota transplantation, FMT）是复发性艰难梭菌感染的推荐治疗方案，同时被研究用于调控其他胃肠道及全身性疾病。自体粪便微生物群移植可降低供体移植材料带来的潜在风险，且可用于预防性治疗。胶囊化粪便微生物群移植便捷易用，但目前缺乏相关安全性数据。 研究目的：本研究旨在对比接受抗生素预处理的健康志愿者中，自体粪便微生物群移植胶囊与安慰剂的安全性与耐受性。 研究方法：招募过去3个月未使用抗生素、粪便艰难梭菌检测呈阴性的健康志愿者。受试者捐赠粪便用于制备含自身微生物群的胶囊。随后给予受试者克林霉素治疗7天以扰乱肠道微生物群，之后进行2天的洗脱期。将受试者按1:1比例随机分配至自体粪便制剂组或安慰剂组，以每日2次、每次2粒的剂量接受为期5天的自行给药治疗。受试者需填写标准化不良反应与耐受性问卷，随访至第28天每日填报1次，另分别于第60天和第180天再次填报。 研究结果：共纳入24名受试者，全部完成治疗。安慰剂组与胶囊化FMT组各有1名受试者分别于第21天和第60天失访。无受试者出现严重不良反应，但有2名受试者在克林霉素治疗期间报告重度疲劳。报告的不良反应均为轻至中度，两组间无显著差异。抗生素治疗后，两组受试者报告的整体健康与肠道健康状况均显著改善，且改善趋势相似。安慰剂组与胶囊化FMT组受试者从研究启动至肠道习惯恢复正常的时间分别为17天和19天（p=0.8）。 研究结论：冷冻胶囊化自体粪便微生物群移植具有良好的安全性与耐受性，但与安慰剂相比，未显著缩短肠道习惯恢复正常的时间。 试验注册：EudraCT 2017-002418-30。