Luxembourg Centre for Systems Biomedicine, University of Luxembourg, Esch-sur-Alzette, Luxembourg.
Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Berlin, Germany.
BMJ Open. 2023 Aug 18;13(8):e071380. doi: 10.1136/bmjopen-2022-071380.
Chronic inflammatory diseases like rheumatoid arthritis (RA) and neurodegenerative disorders like Parkinson's disease (PD) have recently been associated with a decreased diversity in the gut microbiome, emerging as key driver of various diseases. The specific interactions between gut-borne microorganisms and host pathophysiology remain largely unclear. The microbiome can be modulated by interventions comprising nutrition.The aim of our clinical study is to (1) examine effects of prolonged fasting (PF) and time-restricted eating (TRE) on the outcome parameters and the immunophenotypes of RA and PD with (2) special consideration of microbial taxa and molecules associated with changes expected in (1), and (3) identify factors impacting the disease course and treatment by in-depth screening of microorganisms and molecules in personalised HuMiX gut-on-chip models, to identify novel targets for anti-inflammatory therapy.
This trial is an open-label, multicentre, controlled clinical trial consisting of a cross-sectional and a longitudinal study. A total of 180 patients is recruited. For the cross-sectional study, 60 patients with PD, 60 patients with RA and 60 healthy controls are recruited at two different, specialised clinical sites. For the longitudinal part, 30 patients with PD and 30 patients with RA undergo 5-7 days of PF followed by TRE (16:8) for a period of 12 months. One baseline visit takes place before the PF intervention and 10 follow-up visits will follow over a period of 12 months (April 2021 to November 2023).
Ethical approval was obtained to plan and conduct the trial from the institutional review board of the Charité-Universitätsmedizin Berlin (EA1/204/19), the ethics committee of the state medical association (Landesärztekammer) of Hessen (2021-2230-zvBO) and the Ethics Review Panel (ERP) of the University of Luxembourg (ERP 21-001 A ExpoBiome). The results of this study will be disseminated through peer-reviewed publications, scientific presentations and social media.
NCT04847011.
类风湿关节炎（RA）和帕金森病（PD）等慢性炎症性疾病最近与肠道微生物组多样性降低有关，成为各种疾病的关键驱动因素。肠道传播的微生物与宿主病理生理学之间的具体相互作用在很大程度上仍不清楚。微生物组可以通过包含营养的干预措施进行调节。我们的临床研究目的是：（1）检查长期禁食（PF）和限时进食（TRE）对 RA 和 PD 结果参数和免疫表型的影响，（2）特别考虑与预计变化相关的微生物类群和分子，以及（3）通过深入筛选个性化 HuMiX 肠道芯片模型中的微生物和分子，确定影响疾病进程和治疗的因素，以确定抗炎治疗的新靶点。
这项试验是一项开放标签、多中心、对照临床试验，包括横断面和纵向研究。共招募 180 名患者。对于横断面研究，在两个不同的专门临床地点招募 60 名 PD 患者、60 名 RA 患者和 60 名健康对照者。对于纵向部分，30 名 PD 患者和 30 名 RA 患者接受 5-7 天的 PF 后，进行 12 个月的 TRE（16:8）。在 PF 干预前进行一次基线访视，在 12 个月的时间内进行 10 次随访。
已从柏林查理特医科大学的机构审查委员会（EA1/204/19）、黑森州州立医师协会的伦理委员会（Landesärztekammer）（2021-2230-zvBO）和卢森堡大学伦理审查小组（ERP）获得计划和开展试验的伦理批准（ERP 21-001 A ExpoBiome）。这项研究的结果将通过同行评议的出版物、科学演讲和社交媒体传播。
NCT04847011。
