Thorndal Camilla, Kragsnaes Maja Skov, Nilsson Anna Christine, Holm Dorte Kinggaard, dePont Christensen Rene, Ellingsen Torkell, Kjeldsen Jens, Bjørsum-Meyer Thomas
Department of Surgery, Odense University Hospital, Baagøes Alle 15, Odense 5000, Denmark.
Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
Therap Adv Gastroenterol. 2025 Jan 2;18:17562848241309868. doi: 10.1177/17562848241309868. eCollection 2025.
Little is known about the involvement of gut microbiota in the disease course of diverticulitis and the potential benefits of manipulating the gut milieu. We propose to conduct a randomised placebo-controlled feasibility trial of faecal microbiota transplantation (FMT) given as capsules to patients with acute uncomplicated diverticulitis.
The objective is primarily to investigate the feasibility of clinical safety, explore efficacy associated with FMT in this patient population, and examine changes in patient-reported quality of life and the composition and function of the gut microbiota.
Study protocol for a randomised placebo-controlled trial.
Participants with acute, uncomplicated diverticulitis, as confirmed by computed tomography (CT) scan, will be recruited from Odense University Hospital (Denmark) and randomly assigned to either the intervention group or the control group. The intervention group will consist of 20 patients who receive encapsulated FMT. The control group will also consist of 20 patients, receiving placebo capsules. : Patient safety is monitored by (a) the number of re-admissions and (b) the number of adverse events within 3 months of FMT/placebo; : Reduction in the proportion of patients treated with antibiotics within 3 months following FMT/placebo; : Change from baseline to 3 months in the GI-QLI questionnaire. Results will be analysed using an intention-to-treat approach. Adverse events or unintended consequences will be reported.
This is the first study to investigate the safety and efficacy of FMT in patients with acute uncomplicated diverticulitis. The project has the potential to broaden the knowledge and literature on the role of the intestinal microbiota in diverticulitis, and we believe it will elevate our understanding of cause and effect.
Informed consent is obtained from all participants. The study is approved by the regional ethics committee (ref. S-20230023) and the Danish Data Protection Agency (ref. 24/2435). The trial was registered on clinicaltrials.gov (NCT06254625) on 10th February 2024.
关于肠道微生物群在憩室炎病程中的作用以及调节肠道环境的潜在益处，我们所知甚少。我们提议对急性非复杂性憩室炎患者进行一项随机安慰剂对照的粪便微生物群移植（FMT）胶囊可行性试验。
主要目的是研究临床安全性的可行性，探索FMT对该患者群体的疗效，并检查患者报告的生活质量以及肠道微生物群的组成和功能的变化。
一项随机安慰剂对照试验的研究方案。
通过计算机断层扫描（CT）扫描确诊为急性非复杂性憩室炎的参与者将从欧登塞大学医院（丹麦）招募，并随机分配到干预组或对照组。干预组将包括20名接受胶囊FMT的患者。对照组也将包括20名接受安慰剂胶囊的患者。通过（a）再次入院人数和（b）FMT/安慰剂后3个月内的不良事件数量来监测患者安全；FMT/安慰剂后3个月内接受抗生素治疗的患者比例的降低；GI-QLI问卷从基线到3个月的变化。结果将采用意向性分析方法进行分析。将报告不良事件或意外后果。
这是第一项研究FMT对急性非复杂性憩室炎患者安全性和疗效的研究。该项目有可能拓宽关于肠道微生物群在憩室炎中作用的知识和文献，我们相信它将提升我们对因果关系的理解。
所有参与者均获得知情同意。该研究已获得地区伦理委员会（参考编号：S-20230023）和丹麦数据保护局（参考编号：24/2435）的批准。该试验于2024年2月10日在clinicaltrials.gov上注册（NCT06254625）。
