富含细菌的冻干粪便沉淀物和上清液（细菌计数减少）治疗感染患者的疗效-胶囊粪便微生物群转移的新方法。

BACKGROUND AND AIMS: Faecal microbiota transfer (FMT) has managed to earn its place in the infection (CDI) guidelines by having comparable efficacy and recurrence rate of fidaxomicin. After more than 100 successful FMT administration through nasogastric tube, we started using hard gelatine capsules filled with lyophilised faecal sediment and supernatant. Our main question was whether uncoated capsules (containing faecal sediment or supernatant) are comparable to the widely used nasogastric tubes in CDI. We also investigated the effect of storage and time on the survival rate of bacteria in the samples. METHODS: We compared the efficacy of our capsules to other treatment options of CDI at the Department of Infectology at the University of Pécs (Hungary). For our study, stool was collected from a single donor. We treated 10 patients with relapsing CDI, 5 of them received supernatant, 5 received sediment. Donor samples were stored on 4 different temperatures and tested to determine the survival rates of bacteria. As pilot projects, we also assessed the changes of bacterial taxa, protein- and lipid compositions. Moreover, we selected 4 patients to compare their samples prior and after FMT by using microbiome (16S amplicon sequencing), protein, and lipid analyses. RESULTS: 4 out of the 5 patients who received supernatant became symptomless within 2 days after FMT. In the sediment group 3 out of 5 patients were cured from CDI. Comparing the supernatant to the sediment, we found significantly lower number of colony-forming units in the supernatant. We found that -80°C is the most suitable temperature to store the samples. The stool lipid profiles of recipients showed a more diverse composition after FMT, and changes in the stool protein profiles were observed as well. In the microbiome analysis, we observed an increase in the alpha diversity after FMT. CONCLUSIONS: Our study of 10 patients showed good efficacy of lyophilised faecal supernatant using capsules. The single donor approach proved to be effective in our investigation. A significantly lower CFU number was sufficient for the effect, the separation can be achieved by widely available instruments. For storage temperature, -20°C was sufficient in our clinical practice.

背景和目的：粪便微生物群转移（FMT）在艰难梭菌感染（CDI）指南中具有相当的疗效和 fidaxomicin 复发率，因此得以占据一席之地。在通过鼻胃管成功进行了 100 多次 FMT 给药后，我们开始使用填充冻干粪便沉淀物和上清液的硬明胶胶囊。我们的主要问题是未涂层的胶囊（包含粪便沉淀物或上清液）是否与 CDI 中广泛使用的鼻胃管相当。我们还研究了储存和时间对样本中细菌存活率的影响。

方法：我们比较了我们的胶囊与佩奇大学传染病科（匈牙利）其他 CDI 治疗选择的疗效。为了我们的研究，粪便取自单个供体。我们治疗了 10 例复发性 CDI 患者，其中 5 例接受了上清液，5 例接受了沉淀物。供体样本在 4 种不同温度下储存并进行测试，以确定细菌的存活率。作为试点项目，我们还评估了细菌分类群、蛋白质和脂质组成的变化。此外，我们选择了 4 名患者，通过使用微生物组（16S 扩增子测序）、蛋白质和脂质分析，比较他们 FMT 前后的样本。

结果：接受上清液的 5 名患者中有 4 名在 FMT 后 2 天内症状消失。在沉淀物组中，5 名患者中有 3 名治愈了 CDI。将上清液与沉淀物进行比较，我们发现上清液中的菌落形成单位数量明显较低。我们发现 -80°C 是储存样本的最佳温度。接受者的粪便脂质谱在 FMT 后显示出更丰富的组成，粪便蛋白谱也发生了变化。在微生物组分析中，我们观察到 FMT 后 alpha 多样性增加。

结论：我们对 10 名患者的研究表明，使用胶囊冻干粪便上清液具有良好的疗效。单供体方法在我们的研究中被证明是有效的。较低的 CFU 数量足以达到效果，分离可以通过广泛可用的仪器来实现。对于储存温度，在我们的临床实践中，-20°C 就足够了。