Tkach Sergii, Dorofeyev Andrii, Kuzenko Iurii, Falalyeyeva Tetyana, Tsyryuk Olena, Kovalchuk Oleksandr, Kobyliak Nazarii, Abenavoli Ludovico, Boccuto Luigi
Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine, Kyiv, Ukraine.
Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine.
Front Med (Lausanne). 2023 Jan 12;9:1049849. doi: 10.3389/fmed.2022.1049849. eCollection 2022.
Growing evidence supports the effectiveness of fecal microbiota transplantation (FMT) in treating ulcerative colitis (UC), although its effects seem to depend on the method of introduction, the number of procedures, the donor material, and the severity of UC.
This study aimed to assess FMT's clinical and microbiological efficacy, tolerability, and safety in patients with mild-to-moderate UC.
Patients with mild-to-moderate UC were randomized into two groups. The first group (standard-care, = 27) was treated with basic therapy-mesalazine-at a daily dose of 3 g (2 g orally + 1 g rectally). In the second group (FMT group, = 26), while taking mesalazine at the indicated dose, each patient with UC as add-on therapy underwent a single FMT procedure with fresh material delivered by colonoscopy from a healthy donor. The clinical efficacy of treatment in both groups was evaluated after 4 and 8 weeks. The primary outcome was remission of UC, defined as a partial Mayo score ≤2, and decreased fecal calprotectin. All patients underwent bacteriological examination of feces for quantitative microbiota composition changes.
Clinical response in the form of a significant decrease in stool frequency and a tendency to normalize its consistency after 4 weeks was detected in 14 (51.9%) patients of the standard care group and 16 patients (61.5%) of the FMT group ( = 0.583). The Mayo score in the standard care group was 3.59 ± 1.21 and in the FMT group-3.15±1.04 (=0.166). After 8 weeks, the main primary endpoint was achieved in 70.4% of the standard-care group patients as compared to 84.6% of participants who received FMT as add-on therapy ( = 0.215). A more pronounced decrease in Mayo score was observed in the FMT group compared to the standard-care group (1.34 ± 1.44 vs. 2.14 ± 1.4; = 0.045). All patients also showed a significant decrease in fecal calprotectin levels, which correlated with clinical data, stool frequency, and clinical remission. An improvement in gut microbiota composition was noted in both groups, albeit it was significantly more pronounced in the FMT group.
FTM in patients with mild-to-moderate UC is a well-tolerated, effective, and safe method of treatment in comparison to basic therapy.
https://clinicaltrials.gov/ct2/show/NCT05538026?term=kobyliak&draw=2&rank=4, identifier: NCT05538026.
越来越多的证据支持粪便微生物群移植（FMT）治疗溃疡性结肠炎（UC）的有效性，尽管其效果似乎取决于引入方法、程序次数、供体材料以及UC的严重程度。
本研究旨在评估FMT对轻至中度UC患者的临床和微生物学疗效、耐受性及安全性。
将轻至中度UC患者随机分为两组。第一组（标准治疗组，n = 27）接受基础治疗——美沙拉嗪，每日剂量为3 g（口服2 g + 直肠给药1 g）。第二组（FMT组，n = 26）在按指定剂量服用美沙拉嗪的同时，每位UC患者作为附加治疗接受一次FMT程序，通过结肠镜从健康供体输送新鲜材料。两组治疗4周和8周后评估临床疗效。主要结局是UC缓解，定义为梅奥评分≤2分且粪便钙卫蛋白降低。所有患者均接受粪便细菌学检查以检测微生物群组成的定量变化。
标准治疗组14例（51.9%）患者和FMT组16例（61.5%）患者在4周后出现以大便频率显著降低和大便性状趋于正常为形式的临床反应（P = 0.583）。标准治疗组的梅奥评分为3.59±1.21，FMT组为3.15±1.04（P = 0.166）。8周后，标准治疗组70.4%的患者达到主要主要终点，而接受FMT附加治疗的参与者中这一比例为84.6%（P = 0.215）。与标准治疗组相比，FMT组的梅奥评分下降更为明显（1.34±1.44对2.14±1.4；P = 0.045）。所有患者的粪便钙卫蛋白水平也显著降低，这与临床数据、大便频率和临床缓解相关。两组患者的肠道微生物群组成均有改善，尽管在FMT组中更为明显。
与基础治疗相比，轻至中度UC患者的FTM是一种耐受性良好、有效且安全的治疗方法。
https://clinicaltrials.gov/ct2/show/NCT05538026?term=kobyliak&draw=2&rank=4，标识符：NCT05538026。
