{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T20:31:43Z","timestamp":1786480303310,"version":"build-2736575974"},"reference-count":32,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","funder":[{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["U01 DK096189"],"award-info":[{"award-number":["U01 DK096189"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["U01 DK099923"],"award-info":[{"award-number":["U01 DK099923"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["U01 DK099914"],"award-info":[{"award-number":["U01 DK099914"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["U01 DK099919"],"award-info":[{"award-number":["U01 DK099919"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["R21 DK100772"],"award-info":[{"award-number":["R21 DK100772"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Kidney360"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The intestinal microbiome is an appealing target for interventions in ESKD because of its likely contribution to uremic toxicity. Before conducting clinical trials of microbiome-altering treatments, it is necessary to understand the within-person and between-person variability in the composition and function of the gut microbiome in patients with ESKD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a multicenter, nonrandomized, crossover feasibility study of patients on maintenance hemodialysis consisting of three phases: pretreatment (8 weeks); treatment, during which the prebiotic, p-inulin, was administered at a dosage of 8 g twice daily (12 weeks); and post-treatment (8 weeks). Stool samples were collected 1\u20132 times per week and blood was collected weekly for 28 weeks. The gut microbiome was characterized using 16S ribosomal-RNA sequencing and metabolomic profiling.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 11 of the 13 participants completed the 28-week study. Interparticipant variability was greater than intraparticipant variability for microbiome composition (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.001 by UniFrac distances) and metabolomic composition (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.001 by Euclidean distances). p-Inulin was well tolerated by 12 of 13 participants. Adherence to the frequent sample collection and self-aliquoting of stool samples were both 96%. A change in the microbiome composition from pretreatment to post-treatment was evident by the overall shifts in weighted UniFrac distances (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =0.004) and a progressive decrease in prevalence of high intraclass correlations, indicating an increase in intraparticipant microbiome diversity during and after p-inulin treatment. An effect of p-inulin on the metabolomic profile was not evident.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The intraparticipant stability of the gut microbiome under no-treatment conditions, the tolerability of p-inulin, the signals of increased diversity of the microbiome with p-inulin treatment, and the willingness of participants to provide stool samples all support the feasibility of a larger trial to investigate interventions targeting the gut microbiome in patients with ESKD. Whether or not p-inulin has sufficient efficacy as an intervention requires evaluation in larger studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trial registry name and registration number:<\/jats:title>\n                    <jats:p>Gut Microbiome and p-Inulin in Hemodialysis, NCT02572882<\/jats:p>\n                  <\/jats:sec>","DOI":"10.34067\/kid.0006132020","type":"journal-article","created":{"date-parts":[[2021,1,15]],"date-time":"2021-01-15T17:50:15Z","timestamp":1610733015000},"page":"445-455","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":9,"title":["The Microbiome and p-Inulin in Hemodialysis: A Feasibility Study"],"prefix":"10.34067","volume":"2","clinical-trial-number":[{"clinical-trial-number":"nct02572882","registry":"10.18810\/clinical-trials-gov","type":"results"}],"author":[{"given":"Dominic S.","family":"Raj","sequence":"first","affiliation":[{"name":"Division of Renal Diseases and Hypertension, George Washington University School of Medicine, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael B.","family":"Sohn","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David M.","family":"Charytan","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Medicine, New York University Grossman School of Medicine, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Himmelfarb","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"T. Alp","family":"Ikizler","sequence":"additional","affiliation":[{"name":"Division of Nephrology and Hypertension, Department of Medicine, and Vanderbilt Center for Kidney Disease, Vanderbilt University Medical Center, Nashville, Tennessee"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajnish","family":"Mehrotra","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Department of Medicine, Kidney Research Institute and Harborview Medical Center, University of Washington, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Ramezani","sequence":"additional","affiliation":[{"name":"Division of Renal Diseases and Hypertension, George Washington University School of Medicine, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renu","family":"Regunathan-Shenk","sequence":"additional","affiliation":[{"name":"Division of Renal Diseases and Hypertension, George Washington University School of Medicine, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jesse Y.","family":"Hsu","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Epidemiology and Informatics, and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. Richard","family":"Landis","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Epidemiology and Informatics, and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongzhe","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Epidemiology and Informatics, and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul L.","family":"Kimmel","sequence":"additional","affiliation":[{"name":"National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alan S.","family":"Kliger","sequence":"additional","affiliation":[{"name":"Department of Medicine, Yale School of Medicine, New Haven, Connecticut"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura M.","family":"Dember","sequence":"additional","affiliation":[{"name":"Renal-Electrolyte and Hypertension Division, Department of Medicine, and Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the Hemodialysis Novel Therapies Consortium","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2021,3,25]]},"reference":[{"key":"B1-20250825","doi-asserted-by":"crossref","first-page":"483","DOI":"10.1053\/j.ajkd.2015.09.027","article-title":"Role of the gut microbiome in uremia: A potential therapeutic target","volume":"67","author":"Ramezani","year":"2016","journal-title":"Am J Kidney Dis"},{"key":"B2-20250825","doi-asserted-by":"crossref","first-page":"859","DOI":"10.1152\/physrev.00045.2009","article-title":"Gut microbiota in health and disease","volume":"90","author":"Sekirov","year":"2010","journal-title":"Physiol Rev"},{"key":"B3-20250825","doi-asserted-by":"crossref","first-page":"322","DOI":"10.1053\/j.ajkd.2004.04.048","article-title":"Colonic transit time in long-term dialysis patients","volume":"44","author":"Wu","year":"2004","journal-title":"Am J Kidney Dis"},{"key":"B4-20250825","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1053\/jren.2002.29598","article-title":"Food intake characteristics of hemodialysis patients as obtained by food frequency questionnaire","volume":"12","author":"Kalantar-Zadeh","year":"2002","journal-title":"J Ren Nutr"},{"issue":"Suppl 1","key":"B5-20250825","doi-asserted-by":"crossref","first-page":"4554","DOI":"10.1073\/pnas.1000087107","article-title":"Incomplete recovery and individualized responses of the human distal gut microbiota to repeated antibiotic perturbation","volume":"108","author":"Dethlefsen","year":"2011","journal-title":"Proc Natl Acad Sci U S A"},{"key":"B6-20250825","first-page":"608","article-title":"Pathology of gastrointestinal tract in chronic hemodialysis patients: An autopsy study of 78 cases","volume":"80","author":"Vaziri","year":"1985","journal-title":"Am J Gastroenterol"},{"key":"B7-20250825","doi-asserted-by":"crossref","first-page":"506","DOI":"10.1038\/nrgastro.2014.66","article-title":"Expert consensus document. The International Scientific Association for Probiotics and Prebiotics consensus statement on the scope and appropriate use of the term probiotic","volume":"11","author":"Hill","year":"2014","journal-title":"Nat Rev Gastroenterol Hepatol"},{"key":"B8-20250825","doi-asserted-by":"crossref","first-page":"199","DOI":"10.1681\/nsap.2019.18.4.1","article-title":"Metabolic synergy to uremic toxicity: A tale of symbiosis and dysbiosis in CKD","volume":"18","author":"Paul","year":"2019","journal-title":"NephSAP"},{"key":"B9-20250825","doi-asserted-by":"crossref","first-page":"44","DOI":"10.1016\/j.addr.2016.04.032","article-title":"Microbiome therapeutics \u2013 Advances and challenges","volume":"105","author":"Mimee","year":"2016","journal-title":"Adv Drug Deliv Rev"},{"key":"B10-20250825","doi-asserted-by":"crossref","first-page":"219","DOI":"10.1093\/ndt\/gfp414","article-title":"p-Cresyl sulfate serum concentrations in haemodialysis patients are reduced by the prebiotic oligofructose-enriched inulin","volume":"25","author":"Meijers","year":"2010","journal-title":"Nephrol Dial Transplant"},{"key":"B12-20250825","doi-asserted-by":"crossref","first-page":"75","DOI":"10.1023\/A:1008841022998","article-title":"Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease","volume":"7","author":"Revicki","year":"1998","journal-title":"Qual Life Res"},{"key":"B13-20250825","doi-asserted-by":"crossref","first-page":"101","DOI":"10.3390\/metabo9050101","article-title":"A comprehensive plasma metabolomics dataset for a cohort of mouse knockouts within the international mouse phenotyping Consortium","volume":"9","author":"Barupal","year":"2019","journal-title":"Metabolites"},{"key":"B14-20250825","doi-asserted-by":"crossref","first-page":"82","DOI":"10.3390\/metabo9050082","article-title":"Multi-omics analyses detail metabolic reprogramming in lipids, carnitines, and use of glycolytic intermediates between prostate small cell neuroendocrine carcinoma and prostate adenocarcinoma","volume":"9","author":"Gao","year":"2019","journal-title":"Metabolites"},{"key":"B15-20250825","doi-asserted-by":"crossref","first-page":"30.4.1","DOI":"10.1002\/0471142727.mb3004s114","article-title":"Metabolomics by gas chromatography-mass spectrometry: Combined targeted and untargeted profiling","volume":"114","author":"Fiehn","year":"2016","journal-title":"Curr Protoc Mol Biol"},{"key":"B16-20250825","doi-asserted-by":"crossref","first-page":"523","DOI":"10.1038\/nmeth.3393","article-title":"MS-DIAL: Data-independent MS\/MS deconvolution for comprehensive metabolome analysis","volume":"12","author":"Tsugawa","year":"2015","journal-title":"Nat Methods"},{"key":"B17-20250825","doi-asserted-by":"crossref","first-page":"143","DOI":"10.1080\/00223980.1969.10543491","article-title":"Approximate randomization tests","volume":"72","author":"Edgington","year":"1969","journal-title":"J Psychol"},{"key":"B20-20250825","doi-asserted-by":"crossref","first-page":"2106","DOI":"10.1093\/bioinformatics\/bts342","article-title":"Associating microbiome composition with environmental covariates using generalized UniFrac distances","volume":"28","author":"Chen","year":"2012","journal-title":"Bioinformatics"},{"key":"B21-20250825","doi-asserted-by":"crossref","first-page":"289","DOI":"10.1111\/j.2517-6161.1995.tb02031.x","article-title":"Controlling the false discovery rate: A practical and powerful approach to multiple testing","volume":"57","author":"Benjamini","year":"1995","journal-title":"J R Stat Soc Series B-Methodol"},{"key":"B22-20250825","doi-asserted-by":"crossref","first-page":"2461","DOI":"10.1093\/bioinformatics\/btv183","article-title":"Power and sample-size estimation for microbiome studies using pairwise distances and PERMANOVA","volume":"31","author":"Kelly","year":"2015","journal-title":"Bioinformatics"},{"key":"B23-20250825","doi-asserted-by":"crossref","first-page":"2257","DOI":"10.1136\/gutjnl-2018-317561","article-title":"Gut microbiota dynamics and uraemic toxins: One size does not fit all","volume":"68","author":"Joossens","year":"2019","journal-title":"Gut"},{"key":"B24-20250825","doi-asserted-by":"crossref","first-page":"e0186010","DOI":"10.1371\/journal.pone.0186010","article-title":"Spontaneous variability of pre-dialysis concentrations of uremic toxins over time in stable hemodialysis patients","volume":"12","author":"Eloot","year":"2017","journal-title":"PLoS One"},{"key":"B25-20250825","doi-asserted-by":"crossref","first-page":"630","DOI":"10.1038\/nrmicro.2017.58","article-title":"The resilience of the intestinal microbiota influences health and disease","volume":"15","author":"Sommer","year":"2017","journal-title":"Nat Rev Microbiol"},{"key":"B26-20250825","doi-asserted-by":"crossref","first-page":"223","DOI":"10.2215\/CJN.05240515","article-title":"Synbiotics easing renal failure by improving gut microbiology (SYNERGY): A randomized trial","volume":"11","author":"Rossi","year":"2016","journal-title":"Clin J Am Soc Nephrol"},{"key":"B27-20250825","doi-asserted-by":"crossref","first-page":"1087","DOI":"10.1093\/ajcn\/nqz337","article-title":"Inulin-type fructan intervention restricts the increase in gut microbiome-generated indole in patients with peritoneal dialysis: A randomized crossover study","volume":"111","author":"Li","year":"2020","journal-title":"Am J Clin Nutr"},{"key":"B28-20250825","doi-asserted-by":"crossref","first-page":"1881","DOI":"10.1093\/jn\/134.8.1881","article-title":"The fermentation of different dietary fibers is associated with fecal clostridia levels in men","volume":"134","author":"Chinda","year":"2004","journal-title":"J Nutr"},{"key":"B29-20250825","doi-asserted-by":"crossref","first-page":"1081","DOI":"10.1038\/sj.ki.5000115","article-title":"Free serum concentrations of the protein-bound retention solute p-cresol predict mortality in hemodialysis patients","volume":"69","author":"Bammens","year":"2006","journal-title":"Kidney Int"},{"key":"B30-20250825","doi-asserted-by":"crossref","first-page":"1551","DOI":"10.2215\/CJN.03980609","article-title":"Serum indoxyl sulfate is associated with vascular disease and mortality in chronic kidney disease patients","volume":"4","author":"Barreto","year":"2009","journal-title":"Clin J Am Soc Nephrol"},{"key":"B31-20250825","doi-asserted-by":"crossref","first-page":"448","DOI":"10.1161\/CIRCRESAHA.116.305360","article-title":"Gut microbiota-dependent trimethylamine N-oxide (TMAO) pathway contributes to both development of renal insufficiency and mortality risk in chronic kidney disease","volume":"116","author":"Tang","year":"2015","journal-title":"Circ Res"},{"key":"B32-20250825","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1186\/s12986-019-0343-x","article-title":"Effects of fermentable high fiber diet supplementation on gut derived and conventional nitrogenous product in patients on maintenance hemodialysis: A randomized controlled trial","volume":"16","author":"Khosroshahi","year":"2019","journal-title":"Nutr Metab (Lond)"},{"key":"B33-20250825","doi-asserted-by":"crossref","first-page":"e0153893","DOI":"10.1371\/journal.pone.0153893","article-title":"The influence of prebiotic arabinoxylan oligosaccharides on microbiota derived uremic retention solutes in patients with chronic kidney disease: A randomized controlled trial","volume":"11","author":"Poesen","year":"2016","journal-title":"PLoS One"},{"key":"B34-20250825","doi-asserted-by":"crossref","first-page":"3072","DOI":"10.1016\/j.celrep.2018.02.060","article-title":"Diet, genetics, and the gut microbiome drive dynamic changes in plasma metabolites","volume":"22","author":"Fujisaka","year":"2018","journal-title":"Cell Rep"},{"key":"B35-20250825","doi-asserted-by":"crossref","first-page":"7091718","DOI":"10.1155\/2020\/7091718","article-title":"Uridine metabolism and its role in glucose, lipid, and amino acid homeostasis","volume":"2020","author":"Zhang","year":"2020","journal-title":"BioMed Res Int"}],"container-title":["Kidney360"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.ovid.com\/10.34067\/KID.0006132020","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,11]],"date-time":"2026-08-11T20:02:29Z","timestamp":1786478549000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ovid.com\/10.34067\/KID.0006132020"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3]]},"references-count":32,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2021]]}},"URL":"https:\/\/doi.org\/10.34067\/kid.0006132020","relation":{},"ISSN":["2641-7650"],"issn-type":[{"value":"2641-7650","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,3]]},"assertion":[{"value":"2020-10-13","name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-01-14","name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}}]}}