Faculty of Medicine and Health, School of Pharmacy, The University of Sydney, Sydney, New South Wales, Australia.
College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.
BMC Musculoskelet Disord. 2023 Feb 27;24(1):150. doi: 10.1186/s12891-023-06259-3.
Fibromyalgia a common idiopathic condition affecting around 1.4% of adults globally. Its signature symptom is chronic widespread pain, with a constellation of somatic and psychological symptoms. Fibromyalgia is associated with significant reductions in quality of life, yet to date there is no biochemical marker for its diagnosis. Previous studies have indicated a strong association with gastrointestinal dysfunction, and more recently, alterations to the gut microbiome. No studies have examined the inter-relationship between fibromyalgia, gastrointestinal dysfunction, and the microbiome. This prospective observational case-controlled study will gather data on gastrointestinal function, dietary intake, fermentation patterns of ingested carbohydrates, and symptoms commonly associated with fibromyalgia. These will be evaluated alongside human gene expression and metatranscriptomic analysis of the oral and faecal microbiome.
Adult women aged ≥18 years diagnosed with fibromyalgia and/or meeting ACR 2016 criteria, and healthy family or age-matched controls will be recruited from the community. From consenting participants, we will collect detailed survey information and samples of blood, urine, stool, saliva, and breath.
This is the first prospective study examining interactions between digestive function, human gene expression, and the gut microbiome together with general, and fibromyalgia-specific, symptoms experienced by New Zealand women. This exploration will allow an in-depth understanding of clinically relevant factors that are associated with fibromyalgia and will guide further research and contribute to improved management of this poorly understood condition.
The study was approved by the New Zealand Health and Disability Committee (HDEC) (ref: 20/CEN/197) and registered with the Australia and New Zealand Clinical Trials Registry (ANZCTR), registration number ACTRN12620001337965. Written consent will be obtained after providing participants with detailed information about the procedures. Access to data will be restricted to the immediate research team, and all samples and survey data will be deidentified and coded before analysis.
纤维肌痛是一种常见的特发性疾病，全球约有 1.4%的成年人受其影响。其特征性症状是慢性广泛性疼痛，并伴有一系列躯体和心理症状。纤维肌痛会显著降低生活质量，但迄今为止，其诊断尚无生化标志物。先前的研究表明，它与胃肠道功能障碍有很强的关联，最近还与肠道微生物组的改变有关。目前还没有研究探讨纤维肌痛、胃肠道功能障碍和微生物组之间的相互关系。本前瞻性观察性病例对照研究将收集胃肠道功能、饮食摄入、摄入碳水化合物的发酵模式以及与纤维肌痛常见相关的症状等方面的数据。这些将与人类基因表达和口腔及粪便微生物组的宏转录组分析一起进行评估。
将从社区招募年龄在 18 岁及以上、诊断为纤维肌痛和/或符合 ACR 2016 标准的成年女性患者和健康的家族或年龄匹配的对照组。从同意的参与者中，我们将收集详细的调查信息和血液、尿液、粪便、唾液和呼气样本。
这是第一项检查新西兰女性的消化功能、人类基因表达和肠道微生物组与一般和纤维肌痛特异性症状之间相互作用的前瞻性研究。这项探索将深入了解与纤维肌痛相关的临床相关因素，并为进一步的研究提供指导，有助于改善对这种理解不足的疾病的管理。
该研究已获得新西兰健康和残疾委员会（HDEC）的批准（编号：20/CEN/197），并在澳大利亚和新西兰临床试验注册中心（ANZCTR）注册，注册号为 ACTRN12620001337965。在向参与者提供有关程序的详细信息后，将获得书面同意。将限制对数据的访问权限，仅限于直接的研究团队，在分析之前，所有样本和调查数据将被去识别和编码。
