Department of Medicine, Stord Hospital, Stord, Norway; Department of Clinical Medicine and Department of Gastroenterology, Faculty of Medicine and Dentistry, University of Bergen, Bergen, Norway.
Department of Medicine, Stord Hospital, Stord, Norway.
Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14.
BACKGROUND & AIMS: The long-term efficacy and possible adverse events of fecal microbiota transplantation (FMT) for irritable bowel syndrome (IBS) are unknown. This study performed a 3-year follow-up of the patients in our previous clinical trial to clarify these aspects.
This study included 125 patients (104 females, and 21 males): 38 in a placebo group, 42 who received 30 g of donor feces, and 45 who received 60 g of donor feces. Feces was administered to the duodenum. The patients provided a fecal sample and completed 5 questionnaires at baseline and at 2 and 3 years after FMT. Fecal bacteria and dysbiosis index were analyzed using 16S ribosomal RNA gene polymerase chain reaction DNA amplification/probe hybridization covering the V3 to V9 regions.
Response rates were 26.3%, 69.1%, and 77.8% in the placebo, 30-g, and 60-g groups, respectively, at 2 years after FMT, and 27.0%, 64.9%, and 71.8%, respectively, at 3 years after FMT. The response rates were significantly higher in the 30-g and 60-g groups than in the placebo group. Patients in the 30-g and 60-g groups had significantly fewer IBS symptoms and fatigue, and a greater quality of life both at 2 and 3 years after FMT. The dysbiosis index decreased only in the active treatment groups at 2 and 3 years after FMT. Fluorescent signals of 10 bacteria had significant correlations with IBS symptoms and fatigue after FMT in the 30-g and 60-g groups. No long-term adverse events were recorded.
FMT performed according to our protocol resulted in high response rates and long-standing effects with only few mild self-limited adverse events. This study was registered at www.
gov (NCT03822299).
粪菌移植（FMT）治疗肠易激综合征（IBS）的长期疗效和可能的不良反应尚不清楚。本研究对我们之前临床试验中的患者进行了 3 年随访，以阐明这些方面。
本研究纳入了 125 名患者（104 名女性，21 名男性）：安慰剂组 38 名，接受 30g 供体粪便的 42 名，接受 60g 供体粪便的 45 名。粪便被注入十二指肠。患者在基线时和 FMT 后 2 年和 3 年均提供粪便样本并完成 5 份问卷。使用 16S 核糖体 RNA 基因聚合酶链反应 DNA 扩增/探针杂交分析粪便细菌和肠道菌群失调指数，涵盖 V3 至 V9 区。
FMT 后 2 年时，安慰剂组、30g 组和 60g 组的应答率分别为 26.3%、69.1%和 77.8%，FMT 后 3 年时分别为 27.0%、64.9%和 71.8%。30g 组和 60g 组的应答率显著高于安慰剂组。30g 组和 60g 组患者在 FMT 后 2 年和 3 年均具有更少的 IBS 症状和疲劳，更高的生活质量。FMT 后 2 年和 3 年时，只有在积极治疗组中肠道菌群失调指数降低。FMT 后 30g 组和 60g 组中，10 种细菌的荧光信号与 IBS 症状和疲劳有显著相关性。未记录到长期不良反应。
根据我们的方案进行的 FMT 治疗具有较高的应答率和长期效果，仅有少数轻微的自限性不良反应。本研究在 www.clinicaltrials.gov 注册（NCT03822299）。
