{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,16]],"date-time":"2025-10-16T00:36:14Z","timestamp":1760574974281,"version":"build-2065373602"},"reference-count":39,"publisher":"MDPI AG","issue":"20","license":[{"start":{"date-parts":[[2025,10,12]],"date-time":"2025-10-12T00:00:00Z","timestamp":1760227200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Chonnam National University Hwasun Hospital Institute for Biomedical Science","award":["HCRI23015"],"award-info":[{"award-number":["HCRI23015"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: The gut microbiome is crucial in sustaining intestinal balance and general health. Following rectal cancer surgery, the creation of a diverting stoma to protect the anastomosis results in a defunctioned colon, leading to dysbiosis. The effect of probiotic intake on gut dysbiosis following ileostomy repair remains uncertain. Thus, this study aims to determine the changes in gut microbiota based on the intake of probiotics after diverting stoma repair. Methods: This single-center, parallel, prospective pilot study will include patients with primary rectal cancer planning to undergo a diverting stoma during rectal cancer surgery. The study will comprise 20 patients, with 10 patients receiving synbiotics after stoma repair and 10 patients not receiving probiotics. The primary endpoint is the change in the gut microbiota of the resting colon based on the intake of probiotics, assessed through fecal testing at the following time points: before bowel resection, immediately after diverting stoma repair, and 3 weeks after diverting stoma repair. Changes in gut microbiota will be evaluated using alpha- and beta-diversity analyses based on 16S rRNA sequencing of fecal samples. Discussion: This study is the first prospective cohort trial investigating changes in the gut microbiota of the resting colon based on oral probiotic administration in patients undergoing diverting stoma repair. This trial is anticipated to clarify the impact of probiotic intake in these patients. Trial registration: Clinical Research Information Service (CRIS) of the Republic of Korea, KCT0008392, Registered on 27 April 2023.<\/jats:p>","DOI":"10.3390\/jcm14207190","type":"journal-article","created":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T10:12:29Z","timestamp":1760523149000},"page":"7190","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Changes in Gut Microbiome According to Probiotic Intake in Rectal Cancer Patients Undergoing Diverting Stoma Repair: Study Protocol"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6818-1109","authenticated-orcid":false,"given":"Hyeung-min","family":"Park","sequence":"first","affiliation":[{"name":"Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, Hwasun 58128, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jaram","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, Hwasun 58128, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9200-7933","authenticated-orcid":false,"given":"Soo Young","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, Hwasun 58128, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chang Hyun","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, Hwasun 58128, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hyeong Rok","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, Hwasun 58128, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,10,12]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"734","DOI":"10.1177\/0884533615609899","article-title":"Gut Microbiome: What We Do and Don\u2019t Know","volume":"30","author":"Cresci","year":"2015","journal-title":"Nutr. Clin. Pract."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"8787","DOI":"10.3748\/wjg.v21.i29.8787","article-title":"Role of the normal gut microbiota","volume":"21","author":"Jandhyala","year":"2015","journal-title":"World J. Gastroenterol."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1867","DOI":"10.1136\/gutjnl-2020-321153","article-title":"The role of gut microbiota in cancer treatment: Friend or foe?","volume":"69","author":"Cheng","year":"2020","journal-title":"Gut"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"800","DOI":"10.1038\/nrc3610","article-title":"The microbiome and cancer","volume":"13","author":"Schwabe","year":"2013","journal-title":"Nat. Rev. Cancer"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1164","DOI":"10.1007\/s10350-004-6384-9","article-title":"Value of a protective stoma in low anterior resections for rectal cancer","volume":"45","author":"Marusch","year":"2002","journal-title":"Dis. Colon Rectum"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"796","DOI":"10.1136\/gut.2006.102046","article-title":"The effect of faecal diversion on human ileum","volume":"56","author":"Williams","year":"2007","journal-title":"Gut"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"1157","DOI":"10.1002\/ueg2.12175","article-title":"Diversion proctocolitis and the problem of the forgotten rectum in inflammatory bowel diseases: A systematic review","volume":"9","author":"Carvello","year":"2021","journal-title":"United Eur. Gastroenterol. J."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1088","DOI":"10.1016\/j.ijsu.2014.08.350","article-title":"Pathophysiology, clinical presentation and management of diversion colitis: A review of current literature","volume":"12","author":"Kabir","year":"2014","journal-title":"Int. J. Surg."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1734","DOI":"10.3748\/wjg.v24.i16.1734","article-title":"Diversion colitis and pouchitis: A mini-review","volume":"24","author":"Tominaga","year":"2018","journal-title":"World J. Gastroenterol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"40","DOI":"10.1186\/s13099-023-00566-9","article-title":"Dysbiosis of gut microbiota during fecal stream diversion in patients with colorectal cancer","volume":"15","author":"Lee","year":"2023","journal-title":"Gut Pathog."},{"key":"ref_11","doi-asserted-by":"crossref","unstructured":"Martinez, E., Taminiau, B., Rodriguez, C., and Daube, G. (2022). Gut Microbiota Composition Associated with Clostridioides difficile Colonization and Infection. Pathogens, 11.","DOI":"10.3390\/pathogens11070781"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"994","DOI":"10.1111\/codi.14636","article-title":"Preoperative bowel stimulation prior to ileostomy closure to restore bowel function more quickly and improve postoperative outcomes: A systematic review","volume":"21","author":"Rombey","year":"2019","journal-title":"Color. Dis."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"67","DOI":"10.1046\/j.1440-1711.2000.00887.x","article-title":"Modulating immune responses with probiotic bacteria","volume":"78","author":"Matsuzaki","year":"2000","journal-title":"Immunol. Cell Biol."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"43","DOI":"10.1017\/S1751731114002584","article-title":"A review on prebiotics and probiotics for the control of dysbiosis: Present status and future perspectives","volume":"9","author":"Ducatelle","year":"2015","journal-title":"Animal"},{"key":"ref_15","first-page":"347","article-title":"Role of the microbiome, probiotics, and \u2018dysbiosis therapy\u2019 in critical illness","volume":"22","author":"Wischmeyer","year":"2016","journal-title":"Curr. Opin. Crit. Care"},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Aschard, H., Laville, V., Tchetgen, E.T., Knights, D., Imhann, F., Seksik, P., Zaitlen, N., Silverberg, M.S., Cosnes, J., and Weersma, R.K. (2019). Genetic effects on the commensal microbiota in inflammatory bowel disease patients. PLoS Genet., 15.","DOI":"10.1371\/journal.pgen.1008018"},{"key":"ref_17","doi-asserted-by":"crossref","unstructured":"Park, I.J., Lee, J.H., Kye, B.H., Oh, H.K., Cho, Y.B., Kim, Y.T., Kim, J.Y., Sung, N.Y., Kang, S.B., and Seo, J.M. (2020). Effects of PrObiotics on the Symptoms and Surgical ouTComes after Anterior REsection of Colon Cancer (POSTCARE): A Randomized, Double-Blind, Placebo-Controlled Trial. J. Clin. Med., 9.","DOI":"10.3390\/jcm9072181"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"eaap8914","DOI":"10.1126\/scitranslmed.aap8914","article-title":"Gut microbiota composition and functional changes in inflammatory bowel disease and irritable bowel syndrome","volume":"10","author":"Imhann","year":"2018","journal-title":"Sci. Transl. Med."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"515","DOI":"10.3892\/ol.2025.15261","article-title":"Exploring the clinical value of probiotics in the perioperative management of colorectal cancer: Meta-analysis with trial sequential analysis","volume":"30","author":"Zhang","year":"2025","journal-title":"Oncol. Lett."},{"key":"ref_20","doi-asserted-by":"crossref","unstructured":"Acevedo-Rom\u00e1n, A., Pag\u00e1n-Zayas, N., Vel\u00e1zquez-Rivera, L.I., Torres-Ventura, A.C., and Godoy-Vitorino, F. (2024). Insights into Gut Dysbiosis: Inflammatory Diseases, Obesity, and Restoration Approaches. Int. J. Mol. Sci., 25.","DOI":"10.3390\/ijms25179715"},{"key":"ref_21","doi-asserted-by":"crossref","unstructured":"Sam, S.W., Hafeez, B., Ong, H.I., Gill, S., Smibert, O., Lavelle, A., Burgess, A., Proud, D., and Mohan, H. (2024). The impact of faecal diversion on the gut microbiome: A systematic review. Gut Microbiome, 5.","DOI":"10.1017\/gmb.2024.1"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"420","DOI":"10.1111\/j.1445-2197.2012.06082.x","article-title":"Clinical trial assessing VSL#3 for the treatment of anterior resection syndrome","volume":"82","author":"Stephens","year":"2012","journal-title":"ANZ J. Surg."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"901","DOI":"10.1111\/codi.15463","article-title":"Effects of probiotics on bowel function restoration following ileostomy closure in rectal cancer patients: A randomized controlled trial","volume":"23","author":"Yoon","year":"2021","journal-title":"Color. Dis."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"200","DOI":"10.7326\/0003-4819-158-3-201302050-00583","article-title":"SPIRIT 2013 statement: Defining standard protocol items for clinical trials","volume":"158","author":"Chan","year":"2013","journal-title":"Ann. Intern. Med."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"628","DOI":"10.1186\/s13063-020-04544-3","article-title":"Effect of preoperative immunonutrition on outcomes of colon cancer surgery: Study protocol for a randomized controlled trial","volume":"21","author":"Lee","year":"2020","journal-title":"Trials"},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"577","DOI":"10.1016\/j.chom.2015.04.008","article-title":"An integrative view of microbiome-host interactions in inflammatory bowel diseases","volume":"17","author":"Wlodarska","year":"2015","journal-title":"Cell Host Microbe"},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"154","DOI":"10.1038\/nrendo.2015.218","article-title":"The role of the intestinal microbiota in type 1 diabetes mellitus","volume":"12","author":"Knip","year":"2016","journal-title":"Nat. Rev. Endocrinol."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"147","DOI":"10.1007\/s00018-015-2061-5","article-title":"Gut microbiota and obesity","volume":"73","year":"2016","journal-title":"Cell Mol. Life Sci."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"369","DOI":"10.1002\/ana.24901","article-title":"The gut microbiome in human neurological disease: A review","volume":"81","author":"Tremlett","year":"2017","journal-title":"Ann. Neurol."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"255","DOI":"10.1056\/NEJMra1005408","article-title":"Necrotizing enterocolitis","volume":"364","author":"Neu","year":"2011","journal-title":"N. Engl. J. Med."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"4182","DOI":"10.1172\/JCI72336","article-title":"Clostridium difficile and the microbiota","volume":"124","author":"Seekatz","year":"2014","journal-title":"J. Clin. Investig."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"281","DOI":"10.4174\/astr.2021.101.5.281","article-title":"The effect of probiotics supplementation in postoperative cancer patients: A prospective pilot study","volume":"101","author":"Kwon","year":"2021","journal-title":"Ann. Surg. Treat. Res."},{"key":"ref_33","doi-asserted-by":"crossref","first-page":"361","DOI":"10.1046\/j.1472-765X.1997.00140.x","article-title":"Recovery of Lactobacillus rhamnosus GG from human colonic biopsies","volume":"24","author":"Alander","year":"1997","journal-title":"Lett. Appl. Microbiol."},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"2578","DOI":"10.1128\/AEM.66.6.2578-2588.2000","article-title":"Analysis of the fecal microflora of human subjects consuming a probiotic product containing Lactobacillus rhamnosus DR20","volume":"66","author":"Tannock","year":"2000","journal-title":"Appl. Environ. Microbiol."},{"key":"ref_35","doi-asserted-by":"crossref","unstructured":"Dahiya, D., and Nigam, P.S. (2022). Nutrition and Health through the Use of Probiotic Strains in Fermentation to Produce Non-Dairy Functional Beverage Products Supporting Gut Microbiota. Foods, 11.","DOI":"10.3390\/foods11182760"},{"key":"ref_36","doi-asserted-by":"crossref","unstructured":"Dahiya, D., and Nigam, P.S. (2023). Antibiotic-Therapy-Induced Gut Dysbiosis Affecting Gut Microbiota-Brain Axis and Cognition: Restoration by Intake of Probiotics and Synbiotics. Int. J. Mol. Sci., 24.","DOI":"10.3390\/ijms24043074"},{"key":"ref_37","doi-asserted-by":"crossref","unstructured":"Rodr\u00edguez-Padilla, \u00c1., Morales-Mart\u00edn, G., P\u00e9rez-Quintero, R., Rada-Morgades, R., G\u00f3mez-Salgado, J., and Ruiz-Frutos, C. (2021). Diversion Colitis and Probiotic Stimulation: Effects of Bowel Stimulation Prior to Ileostomy Closure. Front. Med., 8.","DOI":"10.3389\/fmed.2021.654573"},{"key":"ref_38","first-page":"89","article-title":"Perineal colostomy: Advantages and disadvantages","volume":"17","author":"Mulita","year":"2022","journal-title":"Prz. Gastroenterol."},{"key":"ref_39","doi-asserted-by":"crossref","unstructured":"Verras, G.I., and Mulita, F. (2024). Butyrylcholinesterase levels correlate with surgical site infection risk and severity after colorectal surgery: A prospective single-center study. Front. Surg., 11.","DOI":"10.3389\/fsurg.2024.1379410"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/20\/7190\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T10:38:59Z","timestamp":1760524739000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/20\/7190"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,12]]},"references-count":39,"journal-issue":{"issue":"20","published-online":{"date-parts":[[2025,10]]}},"alternative-id":["jcm14207190"],"URL":"https:\/\/doi.org\/10.3390\/jcm14207190","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,12]]}}}