Cochrane Kidney and Transplant, The Children's Hospital at Westmead, Westmead, Australia.
Sydney School of Public Health, The University of Sydney, Edward Ford Building (A27), Fisher Road, Camperdown, NSW, 2006, Australia.
BMC Nephrol. 2021 Nov 21;22(1):388. doi: 10.1186/s12882-021-02600-x.
Gastro-intestinal (GI) intolerance is a frequently reported outcome in patients with kidney failure receiving maintenance dialysis and those who have received kidney transplants. Symptoms of GI intolerance (diarrhoea, constipation, bloating, abdominal pain, heart burn, and reflux) are associated with significant reduction in quality of life, morbidity, and increased used of healthcare resources. Having chronic kidney disease (CKD), together with related changes in diet and medication, may alter the gut microbiota and the microbial-derived uraemic metabolites that accumulate in kidney failure, and contribute to various complications including chronic diarrhoea, opportunistic infections, and drug-related colitis. Despite the high disease burden among patients with kidney replacement therapies, GI symptoms are often under-recognised and, consequently limited resources and strategies are devoted to the management of gastrointestinal complications in patients with CKD.
The CKD Bowel Health Study is a multi-centre mixed-methods observational longitudinal study to better understand the bowel health and GI symptom management in patients with CKD. The program comprises of a longitudinal study that will assess the burden and risk factors of GI intolerance in patients treated with maintenance dialysis; a semi-structured interview study that will describe experiences of GI intolerance (including symptoms, treatment, self-management) in transplant candidates and recipients; and a discrete choice experience to elicit patient preferences regarding their experiences and perspectives of various intervention strategies for the management of GI symptoms after kidney transplantation.
This proposed program of work aims to define the burden the GI intolerance in patients with kidney failure and generate evidence on the patients' experiences of GI intolerance and their perspectives on their clinical and own management strategies of these symptoms, ensuring a patient-centred approach to guide clinical decision making and to inform the best study design for intervention trials.
This study is registered on the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12621000548831 . This study has been approved by the Western Sydney Local Health District Human Research Ethics Committee of New South Wales Health (HREC ETH03007). This study is supported by a National Health and Medical Research Council (NHMRC) Australia Investigator Grant (APP1195414), and an NHMRC Australia Postgraduate Scholarship (APP2005244).
胃肠道（GI）不耐受是接受维持性透析和肾移植的肾衰竭患者经常报告的结果。GI 不耐受症状（腹泻、便秘、腹胀、腹痛、烧心和反流）与生活质量显著下降、发病率增加和医疗资源使用增加有关。患有慢性肾脏病（CKD），加上饮食和药物相关变化，可能会改变肠道微生物群和在肾衰竭中积累的微生物衍生的尿毒症代谢物，从而导致各种并发症，包括慢性腹泻、机会性感染和药物相关性结肠炎。尽管接受肾脏替代治疗的患者疾病负担很高，但胃肠道症状常常未被识别，因此，用于 CKD 患者胃肠道并发症管理的资源和策略有限。
CKD 肠道健康研究是一项多中心混合方法纵向观察研究，旨在更好地了解 CKD 患者的肠道健康和 GI 症状管理。该计划包括一项纵向研究，评估接受维持性透析治疗的患者 GI 不耐受的负担和危险因素；一项半结构访谈研究，描述移植候选人和接受者的 GI 不耐受经历（包括症状、治疗、自我管理）；以及一项离散选择体验，以了解患者对各种干预策略管理肾移植后 GI 症状的体验和观点。
这项拟议的工作方案旨在确定肾衰竭患者 GI 不耐受的负担，并生成有关患者 GI 不耐受经历及其对自身临床和管理这些症状的策略的观点的证据，确保以患者为中心的方法指导临床决策，并为干预试验提供最佳研究设计。
本研究在澳大利亚新西兰临床试验注册中心（ANZCTR）注册：ACTRN12621000548831。本研究已获得新南威尔士州卫生署西悉尼地方卫生区人类研究伦理委员会（HREC ETH03007）的批准。本研究得到澳大利亚国家卫生和医学研究委员会（NHMRC）澳大利亚研究员拨款（APP1195414）和澳大利亚 NHMRC 研究生奖学金（APP2005244）的支持。
