Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden.
Department of Clinical Sciences Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
PLoS One. 2023 Sep 27;18(9):e0292132. doi: 10.1371/journal.pone.0292132. eCollection 2023.
Faecal 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.
To describe safety and tolerability of capsules containing autologous FMT, compared to placebo, in healthy volunteers treated with antibiotics.
Healthy 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.
Twenty-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).
Capsulized frozen autologous faecal microbiota transplantation was safe and well tolerated but did not affect time to normalized intestinal habits compared to placebo.
EudraCT 2017-002418-30.
粪便微生物群移植（FMT）被推荐用于复发性艰难梭菌感染的治疗，并且正在研究其作为其他胃肠道和全身疾病的潜在调节剂。自体 FMT 限制了供体移植材料的潜在风险，并能够进行预防性治疗。胶囊化 FMT 方便且易于获得，但缺乏安全性数据。
描述在接受抗生素治疗的健康志愿者中，与安慰剂相比，使用含有自体 FMT 的胶囊的安全性和耐受性。
招募过去三个月内未接触抗生素且粪便艰难梭菌检测呈阴性的健康志愿者。研究人员捐献粪便用于生产含有自体微生物群的胶囊。然后，他们接受克林霉素治疗七天以破坏肠道微生物群，随后进行两天的洗脱期。然后，研究人员被随机（1:1）接受非监督性自体粪便或安慰剂治疗，每天两次，每次两粒，连续五天。使用标准化问卷在治疗期间（直至第 28 天）以及治疗后第 60 天和 180 天，每天评估副作用和耐受性。
共纳入 24 名研究人员，均完成了治疗。安慰剂和 FMT 组各有 1 人在第 21 天和第 60 天失访。没有研究人员出现严重副作用，但在抗生素治疗期间有 2 人报告了严重疲劳。报告的副作用为轻度至中度，两组之间无显著差异。两组在抗生素治疗后，一般和肠道健康均显著且相似地改善。安慰剂组和 FMT 组从研究开始到肠道习惯正常化的时间分别为 17 天和 19 天（p = 0.8）。
胶囊化冷冻自体粪便微生物群移植是安全且耐受良好的，但与安慰剂相比，它并没有影响肠道习惯恢复正常的时间。
EudraCT 2017-002418-30。
