Augustijn Quinten J J, Grefhorst Aldo, de Groen Pleun, Wortelboer Koen, Seegers Jos F Ml, Gül Ismail Sahin, Suenaert Peter, Verheij Joanne, de Vos Willem M, Herrema Hilde, Nieuwdorp Max, Holleboom Adriaan G
Department of Experimental Vascular Medicine, Amsterdam University Medical Centres, Amsterdam, Netherlands
University of Amsterdam, Amsterdam, Netherlands.
BMJ Open. 2025 Jan 9;15(1):e088290. doi: 10.1136/bmjopen-2024-088290.
The spectrum of metabolic dysfunction-associated steatotic liver disease (MASLD) is highly prevalent, affecting 30% of the world's population, with a significant risk of hepatic and cardiometabolic complications. Different stages of MASLD are accompanied by distinct gut microbial profiles, and several microbial components have been implicated in MASLD pathophysiology. Indeed, earlier studies demonstrated that hepatic necroinflammation was reduced in individuals with MASLD after allogenic faecal microbiota transplantation (FMT) from healthy donors on a vegan diet. Here, we further investigate the therapeutic potential of gut microbiome modulation using a syntrophic combination of next-generation beneficial bacteria with FMT in individuals with advanced MASLD.
This trial is a randomised, double-blind, placebo-controlled study investigating the therapeutic potential of lyophilised faecal microbiota capsules (LFMCs) in individuals with metabolic dysfunction-associated steatohepatitis. In this study, 48 participants will be randomised 1:1 to receive either healthy vegan donor LFMCs or placebo for 24 weeks. In addition, all participants will be supplemented with a set of next-generation beneficial bacteria, including , pasteurised and subsp. , as well as fructo-oligosaccharides. A liver biopsy will be performed at baseline and at the end of the trial. In addition, participants will be assessed through MRI, FibroScan, blood tests, faecal samples and continuous glucose monitoring. The first participant was enrolled on 25 April 2023.
Ethical approval was obtained from the Medical Ethics Committee of the University Medical Centre of Amsterdam. The results of this study will be disseminated through peer-reviewed journals.
The trial is registered on clinicaltrials.gov (NCT05821010).
代谢功能障碍相关脂肪性肝病（MASLD）范围广泛，在全球30%的人口中流行，具有发生肝脏和心脏代谢并发症的重大风险。MASLD的不同阶段伴有不同的肠道微生物谱，并且几种微生物成分与MASLD的病理生理学有关。事实上，早期研究表明，接受来自纯素饮食健康供体的同种异体粪便微生物群移植（FMT）后，MASLD患者的肝脏坏死性炎症有所减轻。在此，我们进一步研究在晚期MASLD患者中，使用下一代有益细菌与FMT的营养共生组合调节肠道微生物群的治疗潜力。
本试验是一项随机、双盲、安慰剂对照研究，旨在调查冻干粪便微生物群胶囊（LFMCs）对代谢功能障碍相关脂肪性肝炎患者的治疗潜力。在本研究中，48名参与者将按1:1随机分组，接受健康纯素供体的LFMCs或安慰剂治疗24周。此外，所有参与者将补充一组下一代有益细菌，包括巴氏杀菌的[细菌名称]和[细菌名称]亚种，以及低聚果糖。将在基线和试验结束时进行肝活检。此外，将通过MRI、FibroScan、血液检查、粪便样本和连续血糖监测对参与者进行评估。第一名参与者于2023年4月25日入组。
已获得阿姆斯特丹大学医学中心医学伦理委员会的伦理批准。本研究结果将通过同行评审期刊进行传播。
该试验已在clinicaltrials.gov上注册（NCT05821010）。
