The CKD bowel health study: understanding the bowel health and gastrointestinal symptom management in patients with chronic kidney disease: a mixed-methods observational longitudinal study (protocol)
- PMID: 34802445
- PMCID: PMC8606224
- DOI: 10.1186/s12882-021-02600-x
The CKD bowel health study: understanding the bowel health and gastrointestinal symptom management in patients with chronic kidney disease: a mixed-methods observational longitudinal study (protocol)
Abstract
Background: 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.
Methods: 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.
Discussion: 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.
Trial registration: 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).
Keywords: Chronic kidney disease; Dialysis; Discrete choice experiment; Gastrointestinal symptoms; Gut microbiome; Gut microbiota; Kidney transplant; Observational longitudinal study; Qualitative interview; Uremic toxins.
© 2021. The Author(s).
Conflict of interest statement
The authors declare that they have no competing interests to disclose.
Figures
References
-
- Tierce J, Porterfield-Baxa J, Petrilla A, Kilburg A, Ferguson R. Impact of mycophenolate mofetil (MMF)-related gastrointestinal complications and MMF dose alterations on transplant outcomes and healthcare costs in renal transplant recipients. Clin Transpl. 2005;19(6):779–784. doi: 10.1111/j.1399-0012.2005.00421.x. - DOI - PubMed
-
- Galiwango P, Delgado D, Yan R, Kozuszko S, Smith R, Rao V, Ross H. Mycophenolate mofetil dose reduction for gastrointestinal intolerance is associated with increased rates of rejection in heart transplant patients. J Heart Lung Transplant. 2008;27(1):72–77. doi: 10.1016/j.healun.2007.10.012. - DOI - PubMed
-
- Sollinger H, Sundberg A, Leverson G, Voss B, Pirsch J. Mycophenolate mofetil versus enteric-coated mycophenolate sodium: a large, single-center comparison of dose adjustments and outcomes in kidney transplant recipients. Transplantation. 2010;89(4):446–451. doi: 10.1097/TP.0b013e3181ca860d. - DOI - PubMed
-
- Machnicki G, Pefaur J, Gaite L, Linchenco A, Raimondi C, Schiavelli K, et al. Gastrointestinal (GI)-specific patient reported outcomes instruments differentiate between renal transplant patients with or without GI symptoms: results from a south American cohort. Health Qual Life Outcomes. 2008;6:53. doi: 10.1186/1477-7525-6-53. - DOI - PMC - PubMed
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Medical