Rifaximin for sekundær forebygging av tilbakevendende pouchitis
30. juli 2026 oppdatert av: University of North Carolina, Chapel Hill
Selv om mange mennesker vil utvikle tilbakevendende pouchitt (betennelse i ileal pouch-anal anastomose eller J-pouch etter kolektomi for ulcerøs kolitt) etter en første episode av pouchitt, er det foreløpig ingen effektive behandlinger for å forhindre tilbakevendende pouchitt.
Målet med denne studien er å evaluere potensialet for rifaximin, et antibiotikum, for å forhindre tilbakevendende pouchitt etter behandling for en første episode av pouchitis.
I denne studien vil alle pasienter få daglig rifaximin i ett år etter å ha blitt behandlet for en første episode med pouchitt.
Denne studien vil undersøke om folk er villige til å ta rifaximin i ett år med mål om å forhindre tilbakevendende pouchitt.
I tillegg vil denne studien undersøke om pasienter opplever noen uventede bivirkninger av rifaximinbehandling.
Informasjonen oppnådd gjennom denne studien vil potensielt være nyttig for å forbedre vår evne til å forhindre tilbakevendende pouchitt hos pasienter som har en kolektomi for ulcerøs kolitt.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
16
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mikki Sandridge
- Telefonnummer: (919) 843-3873
- E-post: mikki_sandridge@med.unc.edu
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10016
- Rekruttering
- NYU IBD Center
-
Ta kontakt med:
- Nathasha Melukkaran
- Telefonnummer: 646-754-3417
- E-post: Nathasha.melukkaran@nyulangone.org
-
Hovedetterforsker:
- Shannon Chang, MD, MBA
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater, 27599
- Rekruttering
- University of North Carolina
-
Ta kontakt med:
- Mikki Sandridge
- Telefonnummer: 919-843-3873
- E-post: mikki_sandridge@med.unc.edu
-
Hovedetterforsker:
- Edward Barnes, MD, MPH
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Informert samtykke vil bli innhentet før eventuelle studierelaterte prosedyrer
- Alder > 18 og <75 år
- Deltakere med en påvist historie med ulcerøs kolitt og historie med 1,2, modifisert -2 eller 3 trinns Ileal pouch anal anastomosis (IPAA) og fjerning av ileostomi
- Diagnose av første episode av pouchitt innen de første 12 månedene etter fjerning av ileostomi/sluttstadium av IPAA-kirurgi
Ekskluderingskriterier:
- Kjent overfølsomhet overfor rifaximin eller dets metabolitter
- Kjent Crohns sykdom
- Historie om perianal fistel
- Kjent inkontinens på grunn av anal sphincter dysfunksjon
- Kjent irritabel posesyndrom
- Aktiv pågående bekkeninfeksjon/sepsis ved baseline-besøk
- Ny opptreden av høy tarmfrekvens ved akutt pouchitt i de første 4 ukene etter IPAA
- Kjent Clostridoides difficile-infeksjon
- Behov for langtidsbehandling med antibiotika (f. doksycyklin mot akne)
- Kjent aktiv hepatitt B, C, HIV
- Klinisk signifikant leversykdom (primær skleroserende kolangitt med LFTs <1,5 øvre normalgrense kan inkluderes)
- Alvorlig nedsatt leverfunksjon, definert som Child-Pugh klasse C
- Samtidig bruk av p-glykoprotein (P-gp)-hemmere (f. cyklosporin)
- Kjent nedsatt nyrefunksjon med glomerulær filtrasjonshastighet <60 ml/min/1,732
- Fekal mikrobiotatransplantasjon innen 16 uker før fjerning av ileostomi
- Anamnese med malignitet, bortsett fra basalcellekarsinom, ikke-metastatisk plateepitelkarsinom i huden, eller tidligere malignitet med kurativ behandling fullført minst 5 år før screening og ingen tilbakefall.
- Klinisk signifikante laboratorieresultater ved screening eller baseline, som bedømt av etterforskeren fra lokal testing.
- Kvinne som er gravid, ammer eller har til hensikt å bli gravid eller er i fertil alder og ikke bruker en svært effektiv prevensjonsmetode. Kvinner i fertil alder må ha en negativ uringraviditetstest før stoffet utleveres.
- Deltakelse i enhver klinisk utprøving av et godkjent eller ikke-godkjent undersøkelseslegemiddel innen 30 dager før screening.
- Enhver forstyrrelse som etter etterforskerens mening kan sette deltakerens sikkerhet eller overholdelse av protokollen i fare.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Alle deltakere
550 mg Rifaximin (Xifaxan) to ganger daglig x 365 dager
|
Rifaximin 550 MG oral tablett [XIFAXAN] Tas to ganger daglig i opptil 365 dager
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prosentandel av deltakere som utvikler tilbakevendende pouchitis
Tidsramme: 12 måneder
|
Tilbakevendende pouchitt, definert som en andre episode av pouchitis innen en 12-måneders periode etter den første episoden av pouchitis eller behov for langvarig/residiverende antibiotika etter den første 14 dagers perioden (og initiering av rifaximin).
|
12 måneder
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Edward Barnes, MD, MPH, University of North Carolina
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Stewart AL, Hays RD, Ware JE Jr. The MOS short-form general health survey. Reliability and validity in a patient population. Med Care. 1988 Jul;26(7):724-35. doi: 10.1097/00005650-198807000-00007. No abstract available.
- Human Microbiome Project Consortium. Structure, function and diversity of the healthy human microbiome. Nature. 2012 Jun 13;486(7402):207-14. doi: 10.1038/nature11234.
- Sandborn WJ, Tremaine WJ, Batts KP, Pemberton JH, Phillips SF. Pouchitis after ileal pouch-anal anastomosis: a Pouchitis Disease Activity Index. Mayo Clin Proc. 1994 May;69(5):409-15. doi: 10.1016/s0025-6196(12)61634-6.
- Shen B, Achkar JP, Connor JT, Ormsby AH, Remzi FH, Bevins CL, Brzezinski A, Bambrick ML, Fazio VW, Lashner BA. Modified pouchitis disease activity index: a simplified approach to the diagnosis of pouchitis. Dis Colon Rectum. 2003 Jun;46(6):748-53. doi: 10.1007/s10350-004-6652-8.
- Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJMoa1004409.
- Fodor AA, Pimentel M, Chey WD, Lembo A, Golden PL, Israel RJ, Carroll IM. Rifaximin is associated with modest, transient decreases in multiple taxa in the gut microbiota of patients with diarrhoea-predominant irritable bowel syndrome. Gut Microbes. 2019;10(1):22-33. doi: 10.1080/19490976.2018.1460013. Epub 2018 Jul 18.
- Komanduri S, Gillevet PM, Sikaroodi M, Mutlu E, Keshavarzian A. Dysbiosis in pouchitis: evidence of unique microfloral patterns in pouch inflammation. Clin Gastroenterol Hepatol. 2007 Mar;5(3):352-60. doi: 10.1016/j.cgh.2007.01.001.
- Gionchetti P, Rizzello F, Helwig U, Venturi A, Lammers KM, Brigidi P, Vitali B, Poggioli G, Miglioli M, Campieri M. Prophylaxis of pouchitis onset with probiotic therapy: a double-blind, placebo-controlled trial. Gastroenterology. 2003 May;124(5):1202-9. doi: 10.1016/s0016-5085(03)00171-9.
- Penna C, Dozois R, Tremaine W, Sandborn W, LaRusso N, Schleck C, Ilstrup D. Pouchitis after ileal pouch-anal anastomosis for ulcerative colitis occurs with increased frequency in patients with associated primary sclerosing cholangitis. Gut. 1996 Feb;38(2):234-9. doi: 10.1136/gut.38.2.234.
- Carter MJ, Di Giovine FS, Cox A, Goodfellow P, Jones S, Shorthouse AJ, Duff GW, Lobo AJ. The interleukin 1 receptor antagonist gene allele 2 as a predictor of pouchitis following colectomy and IPAA in ulcerative colitis. Gastroenterology. 2001 Oct;121(4):805-11. doi: 10.1053/gast.2001.28017.
- Meier CB, Hegazi RA, Aisenberg J, Legnani PE, Nilubol N, Cobrin GM, Duerr RH, Gorfine SR, Bauer JJ, Sachar DB, Plevy SE. Innate immune receptor genetic polymorphisms in pouchitis: is CARD15 a susceptibility factor? Inflamm Bowel Dis. 2005 Nov;11(11):965-71. doi: 10.1097/01.mib.0000186407.25694.cf.
- Sandborn WJ. Pouchitis following ileal pouch-anal anastomosis: definition, pathogenesis, and treatment. Gastroenterology. 1994 Dec;107(6):1856-60. doi: 10.1016/0016-5085(94)90832-x. No abstract available.
- Duffy M, O'Mahony L, Coffey JC, Collins JK, Shanahan F, Redmond HP, Kirwan WO. Sulfate-reducing bacteria colonize pouches formed for ulcerative colitis but not for familial adenomatous polyposis. Dis Colon Rectum. 2002 Mar;45(3):384-8. doi: 10.1007/s10350-004-6187-z.
- Shen B, Fazio VW, Remzi FH, Bennett AE, Lopez R, Brzezinski A, Oikonomou I, Sherman KK, Lashner BA. Combined ciprofloxacin and tinidazole therapy in the treatment of chronic refractory pouchitis. Dis Colon Rectum. 2007 Apr;50(4):498-508. doi: 10.1007/s10350-006-0828-3.
- Smith FM, Coffey JC, Kell MR, O'Sullivan M, Redmond HP, Kirwan WO. A characterization of anaerobic colonization and associated mucosal adaptations in the undiseased ileal pouch. Colorectal Dis. 2005 Nov;7(6):563-70. doi: 10.1111/j.1463-1318.2005.00833.x.
- Gionchetti P, Rizzello F, Venturi A, Ugolini F, Rossi M, Brigidi P, Johansson R, Ferrieri A, Poggioli G, Campieri M. Antibiotic combination therapy in patients with chronic, treatment-resistant pouchitis. Aliment Pharmacol Ther. 1999 Jun;13(6):713-8. doi: 10.1046/j.1365-2036.1999.00553.x.
- Lovegrove RE, Tilney HS, Heriot AG, von Roon AC, Athanasiou T, Church J, Fazio VW, Tekkis PP. A comparison of adverse events and functional outcomes after restorative proctocolectomy for familial adenomatous polyposis and ulcerative colitis. Dis Colon Rectum. 2006 Sep;49(9):1293-306. doi: 10.1007/s10350-006-0608-0.
- Shen B, Brzezinski A, Fazio VW, Remzi FH, Achkar JP, Bennett AE, Sherman K, Lashner BA. Maintenance therapy with a probiotic in antibiotic-dependent pouchitis: experience in clinical practice. Aliment Pharmacol Ther. 2005 Oct 15;22(8):721-8. doi: 10.1111/j.1365-2036.2005.02642.x.
- Svaninger G, Nordgren S, Oresland T, Hulten L. Incidence and characteristics of pouchitis in the Kock continent ileostomy and the pelvic pouch. Scand J Gastroenterol. 1993 Aug;28(8):695-700. doi: 10.3109/00365529309098275.
- Shen B, Lashner BA, Bennett AE, Remzi FH, Brzezinski A, Achkar JP, Bast J, Bambrick ML, Fazio VW. Treatment of rectal cuff inflammation (cuffitis) in patients with ulcerative colitis following restorative proctocolectomy and ileal pouch-anal anastomosis. Am J Gastroenterol. 2004 Aug;99(8):1527-31. doi: 10.1111/j.1572-0241.2004.30518.x.
- Madden MV, McIntyre AS, Nicholls RJ. Double-blind crossover trial of metronidazole versus placebo in chronic unremitting pouchitis. Dig Dis Sci. 1994 Jun;39(6):1193-6. doi: 10.1007/BF02093783.
- Sambuelli A, Boerr L, Negreira S, Gil A, Camartino G, Huernos S, Kogan Z, Cabanne A, Graziano A, Peredo H, Doldan I, Gonzalez O, Sugai E, Lumi M, Bai JC. Budesonide enema in pouchitis--a double-blind, double-dummy, controlled trial. Aliment Pharmacol Ther. 2002 Jan;16(1):27-34. doi: 10.1046/j.1365-2036.2002.01139.x.
- Mimura T, Rizzello F, Helwig U, Poggioli G, Schreiber S, Talbot IC, Nicholls RJ, Gionchetti P, Campieri M, Kamm MA. Four-week open-label trial of metronidazole and ciprofloxacin for the treatment of recurrent or refractory pouchitis. Aliment Pharmacol Ther. 2002 May;16(5):909-17. doi: 10.1046/j.1365-2036.2002.01203.x.
- Gionchetti P, Rizzello F, Venturi A, Brigidi P, Matteuzzi D, Bazzocchi G, Poggioli G, Miglioli M, Campieri M. Oral bacteriotherapy as maintenance treatment in patients with chronic pouchitis: a double-blind, placebo-controlled trial. Gastroenterology. 2000 Aug;119(2):305-9. doi: 10.1053/gast.2000.9370.
- Mimura T, Rizzello F, Helwig U, Poggioli G, Schreiber S, Talbot IC, Nicholls RJ, Gionchetti P, Campieri M, Kamm MA. Once daily high dose probiotic therapy (VSL#3) for maintaining remission in recurrent or refractory pouchitis. Gut. 2004 Jan;53(1):108-14. doi: 10.1136/gut.53.1.108.
- Miglioli M, Barbara L, Di Febo G, Gozzetti G, Lauri A, Paganelli GM, Poggioli G, Santucci R. Topical administration of 5-aminosalicylic acid: a therapeutic proposal for the treatment of pouchitis. N Engl J Med. 1989 Jan 26;320(4):257. doi: 10.1056/NEJM198901263200423. No abstract available.
- Wischmeyer P, Pemberton JH, Phillips SF. Chronic pouchitis after ileal pouch-anal anastomosis: responses to butyrate and glutamine suppositories in a pilot study. Mayo Clin Proc. 1993 Oct;68(10):978-81. doi: 10.1016/s0025-6196(12)62270-8.
- Tremaine WJ, Sandborn WJ, Wolff BG, Carpenter HA, Zinsmeister AR, Metzger PP. Bismuth carbomer foam enemas for active chronic pouchitis: a randomized, double-blind, placebo-controlled trial. Aliment Pharmacol Ther. 1997 Dec;11(6):1041-6. doi: 10.1046/j.1365-2036.1997.00253.x.
- Fazio VW, Kiran RP, Remzi FH, Coffey JC, Heneghan HM, Kirat HT, Manilich E, Shen B, Martin ST. Ileal pouch anal anastomosis: analysis of outcome and quality of life in 3707 patients. Ann Surg. 2013 Apr;257(4):679-85. doi: 10.1097/SLA.0b013e31827d99a2.
- DuPont HL, Jiang ZD, Ericsson CD, Adachi JA, Mathewson JJ, DuPont MW, Palazzini E, Riopel LM, Ashley D, Martinez-Sandoval F. Rifaximin versus ciprofloxacin for the treatment of traveler's diarrhea: a randomized, double-blind clinical trial. Clin Infect Dis. 2001 Dec 1;33(11):1807-15. doi: 10.1086/323814. Epub 2001 Oct 23.
- Allison J, Herrinton LJ, Liu L, Yu J, Lowder J. Natural history of severe ulcerative colitis in a community-based health plan. Clin Gastroenterol Hepatol. 2008 Sep;6(9):999-1003. doi: 10.1016/j.cgh.2008.05.022.
- Barnes EL, Herfarth HH, Sandler RS, Chen W, Jaeger E, Nguyen VM, Robb AR, Kappelman MD, Martin CF, Long MD. Pouch-Related Symptoms and Quality of Life in Patients with Ileal Pouch-Anal Anastomosis. Inflamm Bowel Dis. 2017 Jul;23(7):1218-1224. doi: 10.1097/MIB.0000000000001119.
- Devaraj B, Kaiser AM. Surgical management of ulcerative colitis in the era of biologicals. Inflamm Bowel Dis. 2015 Jan;21(1):208-20. doi: 10.1097/MIB.0000000000000178.
- Gionchetti P, Rizzello F, Morselli C, Poggioli G, Tambasco R, Calabrese C, Brigidi P, Vitali B, Straforini G, Campieri M. High-dose probiotics for the treatment of active pouchitis. Dis Colon Rectum. 2007 Dec;50(12):2075-82; discussion 2082-4. doi: 10.1007/s10350-007-9068-4. Epub 2007 Oct 13.
- Gower-Rousseau C, Dauchet L, Vernier-Massouille G, Tilloy E, Brazier F, Merle V, Dupas JL, Savoye G, Balde M, Marti R, Lerebours E, Cortot A, Salomez JL, Turck D, Colombel JF. The natural history of pediatric ulcerative colitis: a population-based cohort study. Am J Gastroenterol. 2009 Aug;104(8):2080-8. doi: 10.1038/ajg.2009.177. Epub 2009 May 12.
- Herrinton LJ, Liu L, Lewis JD, Griffin PM, Allison J. Incidence and prevalence of inflammatory bowel disease in a Northern California managed care organization, 1996-2002. Am J Gastroenterol. 2008 Aug;103(8):1998-2006. doi: 10.1111/j.1572-0241.2008.01960.x.
- Kappelman MD, Rifas-Shiman SL, Kleinman K, Ollendorf D, Bousvaros A, Grand RJ, Finkelstein JA. The prevalence and geographic distribution of Crohn's disease and ulcerative colitis in the United States. Clin Gastroenterol Hepatol. 2007 Dec;5(12):1424-9. doi: 10.1016/j.cgh.2007.07.012. Epub 2007 Sep 29.
- Langholz E, Munkholm P, Davidsen M, Binder V. Course of ulcerative colitis: analysis of changes in disease activity over years. Gastroenterology. 1994 Jul;107(1):3-11. doi: 10.1016/0016-5085(94)90054-x.
- Loftus CG, Loftus EV Jr, Harmsen WS, Zinsmeister AR, Tremaine WJ, Melton LJ 3rd, Sandborn WJ. Update on the incidence and prevalence of Crohn's disease and ulcerative colitis in Olmsted County, Minnesota, 1940-2000. Inflamm Bowel Dis. 2007 Mar;13(3):254-61. doi: 10.1002/ibd.20029.
- Pronio A, Montesani C, Butteroni C, Vecchione S, Mumolo G, Vestri A, Vitolo D, Boirivant M. Probiotic administration in patients with ileal pouch-anal anastomosis for ulcerative colitis is associated with expansion of mucosal regulatory cells. Inflamm Bowel Dis. 2008 May;14(5):662-8. doi: 10.1002/ibd.20369.
- Lightner AL, Mathis KL, Dozois EJ, Hahnsloser D, Loftus EV Jr, Raffals LE, Pemberton JH. Results at Up to 30 Years After Ileal Pouch-Anal Anastomosis for Chronic Ulcerative Colitis. Inflamm Bowel Dis. 2017 May;23(5):781-790. doi: 10.1097/MIB.0000000000001061.
- Barnes EL, Jiang Y, Kappelman MD, Long MD, Sandler RS, Kinlaw AC, Herfarth HH. Decreasing Colectomy Rate for Ulcerative Colitis in the United States Between 2007 and 2016: A Time Trend Analysis. Inflamm Bowel Dis. 2020 Jul 17;26(8):1225-1231. doi: 10.1093/ibd/izz247.
- Barnes EL, Herfarth HH, Kappelman MD, Zhang X, Lightner A, Long MD, Sandler RS. Incidence, Risk Factors, and Outcomes of Pouchitis and Pouch-Related Complications in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1583-1591.e4. doi: 10.1016/j.cgh.2020.06.035. Epub 2020 Jun 22.
- Bertucci Zoccali M, Hyman NH, Skowron KB, Rubin M, Cannon LM, Hurst RD, Umanskiy K, Rubin DT, Shogan BD. Exposure to Anti-tumor Necrosis Factor Medications Increases the Incidence of Pouchitis After Restorative Proctocolectomy in Patients With Ulcerative Colitis. Dis Colon Rectum. 2019 Nov;62(11):1344-1351. doi: 10.1097/DCR.0000000000001467.
- Barnes EL, Allin KH, Iversen AT, Herfarth HH, Jess T. Increasing Incidence of Pouchitis Between 1996 and 2018: A Population-Based Danish Cohort Study. Clin Gastroenterol Hepatol. 2023 Jan;21(1):192-199.e7. doi: 10.1016/j.cgh.2022.04.015. Epub 2022 May 5.
- Barnes EL, Kappelman MD, Zhang X, Long MD, Sandler RS, Herfarth HH. Patients With Pouchitis Demonstrate a Significant Cost Burden in the First Two Years After Ileal Pouch-Anal Anastomosis. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2908-2910.e2. doi: 10.1016/j.cgh.2021.09.037. Epub 2021 Oct 2.
- Barnes EL, Kochar B, Jessup HR, Herfarth HH. The Incidence and Definition of Crohn's Disease of the Pouch: A Systematic Review and Meta-analysis. Inflamm Bowel Dis. 2019 Aug 20;25(9):1474-1480. doi: 10.1093/ibd/izz005.
- Frolkis AD, Dykeman J, Negron ME, Debruyn J, Jette N, Fiest KM, Frolkis T, Barkema HW, Rioux KP, Panaccione R, Ghosh S, Wiebe S, Kaplan GG. Risk of surgery for inflammatory bowel diseases has decreased over time: a systematic review and meta-analysis of population-based studies. Gastroenterology. 2013 Nov;145(5):996-1006. doi: 10.1053/j.gastro.2013.07.041. Epub 2013 Jul 27.
- Tsai L, Ma C, Dulai PS, Prokop LJ, Eisenstein S, Ramamoorthy SL, Feagan BG, Jairath V, Sandborn WJ, Singh S. Contemporary Risk of Surgery in Patients With Ulcerative Colitis and Crohn's Disease: A Meta-Analysis of Population-Based Cohorts. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2031-2045.e11. doi: 10.1016/j.cgh.2020.10.039. Epub 2020 Oct 27.
- Romanos J, Samarasekera DN, Stebbing JF, Jewell DP, Kettlewell MG, Mortensen NJ. Outcome of 200 restorative proctocolectomy operations: the John Radcliffe Hospital experience. Br J Surg. 1997 Jun;84(6):814-8.
- Quinn KP, Lightner AL, Faubion WA, Raffals LE. A Comprehensive Approach to Pouch Disorders. Inflamm Bowel Dis. 2019 Feb 21;25(3):460-471. doi: 10.1093/ibd/izy267.
- Herfarth HH, Long MD, Isaacs KL. Use of Biologics in Pouchitis: A Systematic Review. J Clin Gastroenterol. 2015 Sep;49(8):647-54. doi: 10.1097/MCG.0000000000000367.
- Dalal RL, Shen B, Schwartz DA. Management of Pouchitis and Other Common Complications of the Pouch. Inflamm Bowel Dis. 2018 Apr 23;24(5):989-996. doi: 10.1093/ibd/izy020.
- Batista D, Raffals L. Role of intestinal bacteria in the pathogenesis of pouchitis. Inflamm Bowel Dis. 2014 Aug;20(8):1481-6. doi: 10.1097/MIB.0000000000000055.
- Shen B, Lashner B. Can we immunogenotypically and immunophenotypically profile patients who are at risk for pouchitis? Am J Gastroenterol. 2004 Mar;99(3):442-4. doi: 10.1111/j.1572-0241.2004.04096.x. No abstract available.
- Tyler AD, Milgrom R, Stempak JM, Xu W, Brumell JH, Muise AM, Sehgal R, Cohen Z, Koltun W, Shen B, Silverberg MS. The NOD2insC polymorphism is associated with worse outcome following ileal pouch-anal anastomosis for ulcerative colitis. Gut. 2013 Oct;62(10):1433-9. doi: 10.1136/gutjnl-2011-301957. Epub 2012 Aug 9.
- Lammers KM, Ouburg S, Morre SA, Crusius JB, Gionchett P, Rizzello F, Morselli C, Caramelli E, Conte R, Poggioli G, Campieri M, Pena AS. Combined carriership of TLR9-1237C and CD14-260T alleles enhances the risk of developing chronic relapsing pouchitis. World J Gastroenterol. 2005 Dec 14;11(46):7323-9. doi: 10.3748/wjg.v11.i46.7323.
- Lim M, Adams JD, Wilcox M, Finan P, Sagar P, Burke D. An assessment of bacterial dysbiosis in pouchitis using terminal restriction fragment length polymorphisms of 16S ribosomal DNA from pouch effluent microbiota. Dis Colon Rectum. 2009 Aug;52(8):1492-500. doi: 10.1007/DCR.0b013e3181a7b77a.
- Sokol H, Lay C, Seksik P, Tannock GW. Analysis of bacterial bowel communities of IBD patients: what has it revealed? Inflamm Bowel Dis. 2008 Jun;14(6):858-67. doi: 10.1002/ibd.20392.
- Dubinsky V, Reshef L, Bar N, Keizer D, Golan N, Rabinowitz K, Godny L, Yadgar K, Zonensain K, Tulchinsky H, Gophna U, Dotan I. Predominantly Antibiotic-resistant Intestinal Microbiome Persists in Patients With Pouchitis Who Respond to Antibiotic Therapy. Gastroenterology. 2020 Feb;158(3):610-624.e13. doi: 10.1053/j.gastro.2019.10.001. Epub 2019 Oct 9.
- Machiels K, Sabino J, Vandermosten L, Joossens M, Arijs I, de Bruyn M, Eeckhaut V, Van Assche G, Ferrante M, Verhaegen J, Van Steen K, Van Immerseel F, Huys G, Verbeke K, Wolthuis A, de Buck Van Overstraeten A, D'Hoore A, Rutgeerts P, Vermeire S. Specific members of the predominant gut microbiota predict pouchitis following colectomy and IPAA in UC. Gut. 2017 Jan;66(1):79-88. doi: 10.1136/gutjnl-2015-309398. Epub 2015 Sep 30.
- Atarashi K, Suda W, Luo C, Kawaguchi T, Motoo I, Narushima S, Kiguchi Y, Yasuma K, Watanabe E, Tanoue T, Thaiss CA, Sato M, Toyooka K, Said HS, Yamagami H, Rice SA, Gevers D, Johnson RC, Segre JA, Chen K, Kolls JK, Elinav E, Morita H, Xavier RJ, Hattori M, Honda K. Ectopic colonization of oral bacteria in the intestine drives TH1 cell induction and inflammation. Science. 2017 Oct 20;358(6361):359-365. doi: 10.1126/science.aan4526.
- Isaacs KL, Sandler RS, Abreu M, Picco MF, Hanauer SB, Bickston SJ, Present D, Farraye FA, Wolf D, Sandborn WJ; Crohn's and Colitis Foundation of America Clinical Alliance. Rifaximin for the treatment of active pouchitis: a randomized, double-blind, placebo-controlled pilot study. Inflamm Bowel Dis. 2007 Oct;13(10):1250-5. doi: 10.1002/ibd.20187.
- Belluzzi A, Serrani M, Roda G, Bianchi ML, Castellani L, Grazia M, Rosati G, Ugolini G, Roda E. Pilot study: the use of sulfasalazine for the treatment of acute pouchitis. Aliment Pharmacol Ther. 2010 Jan 15;31(2):228-32. doi: 10.1111/j.1365-2036.2009.04163.x. Epub 2009 Oct 10.
- Kuisma J, Mentula S, Jarvinen H, Kahri A, Saxelin M, Farkkila M. Effect of Lactobacillus rhamnosus GG on ileal pouch inflammation and microbial flora. Aliment Pharmacol Ther. 2003 Feb 15;17(4):509-15. doi: 10.1046/j.1365-2036.2003.01465.x.
- Joelsson M, Andersson M, Bark T, Gullberg K, Hallgren T, Jiborn H, Magnusson I, Raab Y, Sjodahl R, Ojerskog B, Oresland T; Swedish Organization for the Study of Inflammatory Bowel Diseases. Allopurinol as prophylaxis against pouchitis following ileal pouch-anal anastomosis for ulcerative colitis. A randomized placebo-controlled double-blind study. Scand J Gastroenterol. 2001 Nov;36(11):1179-84. doi: 10.1080/00365520152584815.
- Welters CF, Heineman E, Thunnissen FB, van den Bogaard AE, Soeters PB, Baeten CG. Effect of dietary inulin supplementation on inflammation of pouch mucosa in patients with an ileal pouch-anal anastomosis. Dis Colon Rectum. 2002 May;45(5):621-7. doi: 10.1007/s10350-004-6257-2.
- Shen B, Pardi DS, Bennett AE, Queener E, Kammer P, Hammel JP, LaPlaca C, Harris MS. The efficacy and tolerability of AST-120 (spherical carbon adsorbent) in active pouchitis. Am J Gastroenterol. 2009 Jun;104(6):1468-74. doi: 10.1038/ajg.2009.138.
- Yasueda A, Mizushima T, Nezu R, Sumi R, Tanaka M, Nishimura J, Kai Y, Hirota M, Osawa H, Nakajima K, Mori M, Ito T. The effect of Clostridium butyricum MIYAIRI on the prevention of pouchitis and alteration of the microbiota profile in patients with ulcerative colitis. Surg Today. 2016 Aug;46(8):939-49. doi: 10.1007/s00595-015-1261-9. Epub 2015 Oct 29.
- Ha CY, Bauer JJ, Lazarev M, et al. 488 Early Institution of Tinidazole May Prevent Pouchitis Following Ileal-Pouch Anal Anastomosis (IPAA) Surgery in Ulcerative Colitis (UC) Patients. Gastroenterology 2010;138:S-69.
- Nguyen N, Zhang B, Holubar SD, Pardi DS, Singh S. Treatment and prevention of pouchitis after ileal pouch-anal anastomosis for chronic ulcerative colitis. Cochrane Database Syst Rev. 2019 May 28;5(5):CD001176. doi: 10.1002/14651858.CD001176.pub4.
- American Gastroenterological Association Institute Clinical Guidelines C. American Gastroenterological Association Guidelines in Development, 2023.
- Steffen R. Rifaximin: a nonabsorbed antimicrobial as a new tool for treatment of travelers' diarrhea. J Travel Med. 2001 Dec;8(Suppl 2):S34-9. doi: 10.1111/j.1708-8305.2001.tb00545.x. No abstract available.
- DuPont HL, Haake R, Taylor DN, Ericsson CD, Jiang ZD, Okhuysen PC, Steffen R. Rifaximin treatment of pathogen-negative travelers' diarrhea. J Travel Med. 2007 Jan-Feb;14(1):16-9. doi: 10.1111/j.1708-8305.2006.00084.x.
- Taylor DN, Bourgeois AL, Ericsson CD, Steffen R, Jiang ZD, Halpern J, Haake R, Dupont HL. A randomized, double-blind, multicenter study of rifaximin compared with placebo and with ciprofloxacin in the treatment of travelers' diarrhea. Am J Trop Med Hyg. 2006 Jun;74(6):1060-6.
- Steffen R, Sack DA, Riopel L, Jiang ZD, Sturchler M, Ericsson CD, Lowe B, Waiyaki P, White M, DuPont HL. Therapy of travelers' diarrhea with rifaximin on various continents. Am J Gastroenterol. 2003 May;98(5):1073-8. doi: 10.1111/j.1572-0241.2003.07283.x.
- Dupont HL, Jiang ZD, Belkind-Gerson J, Okhuysen PC, Ericsson CD, Ke S, Huang DB, Dupont MW, Adachi JA, De La Cabada FJ, Taylor DN, Jaini S, Martinez Sandoval F. Treatment of travelers' diarrhea: randomized trial comparing rifaximin, rifaximin plus loperamide, and loperamide alone. Clin Gastroenterol Hepatol. 2007 Apr;5(4):451-6. doi: 10.1016/j.cgh.2007.02.004. Epub 2007 Mar 26.
- Bajaj JS, Barbara G, DuPont HL, Mearin F, Gasbarrini A, Tack J. New concepts on intestinal microbiota and the role of the non-absorbable antibiotics with special reference to rifaximin in digestive diseases. Dig Liver Dis. 2018 Aug;50(8):741-749. doi: 10.1016/j.dld.2018.04.020. Epub 2018 Apr 27.
- Dhiman RK, Thumburu KK, Verma N, Chopra M, Rathi S, Dutta U, Singal AK, Taneja S, Duseja A, Singh M. Comparative Efficacy of Treatment Options for Minimal Hepatic Encephalopathy: A Systematic Review and Network Meta-Analysis. Clin Gastroenterol Hepatol. 2020 Apr;18(4):800-812.e25. doi: 10.1016/j.cgh.2019.08.047. Epub 2019 Aug 30.
- Han X, Luo Z, Wang W, Zheng P, Li T, Mei Z, Wang J. Efficacy and Safety of Rifaximin Versus Placebo or Other Active Drugs in Critical ill Patients With Hepatic Encephalopathy. Front Pharmacol. 2021 Oct 8;12:696065. doi: 10.3389/fphar.2021.696065. eCollection 2021.
- Schoenfeld P, Pimentel M, Chang L, Lembo A, Chey WD, Yu J, Paterson C, Bortey E, Forbes WP. Safety and tolerability of rifaximin for the treatment of irritable bowel syndrome without constipation: a pooled analysis of randomised, double-blind, placebo-controlled trials. Aliment Pharmacol Ther. 2014 May;39(10):1161-8. doi: 10.1111/apt.12735. Epub 2014 Apr 3.
- Shen B, Remzi FH, Lopez AR, Queener E. Rifaximin for maintenance therapy in antibiotic-dependent pouchitis. BMC Gastroenterol. 2008 Jun 23;8:26. doi: 10.1186/1471-230X-8-26.
- Esckilsen S, Kochar B, Weaver KN, Herfarth HH, Barnes EL. Very Early Pouchitis Is Associated with an Increased Likelihood of Chronic Inflammatory Conditions of the Pouch. Dig Dis Sci. 2023 Jul;68(7):3139-3147. doi: 10.1007/s10620-023-07947-9. Epub 2023 May 6.
- Kayal M, Kohler D, Plietz M, Khaitov S, Sylla P, Greenstein A, Dubinsky MC. Early Pouchitis Is Associated With Crohn's Disease-like Pouch Inflammation in Patients With Ulcerative Colitis. Inflamm Bowel Dis. 2022 Dec 1;28(12):1821-1825. doi: 10.1093/ibd/izac012.
- Quinn KP, Raffals LE. An Update on the Medical Management of Inflammatory Pouch Complications. Am J Gastroenterol. 2020 Sep;115(9):1439-1450. doi: 10.14309/ajg.0000000000000666.
- Feagan BG, Sands B, Siegel CA, et al. DOP87 The Anti-TL1A Antibody PRA023 Demonstrated Proof-of-Concept in Crohn's Disease: Phase 2a APOLLO-CD Study Results. Journal of Crohn's and Colitis 2023;17:i162-i164.
- Barnes EL, Long MD, Raffals L, Isaacs K, Stidham RW, Herfarth HH; Contributors. Development of the Endoscopic Pouch Score for Assessment of Inflammatory Conditions of the Pouch. Clin Gastroenterol Hepatol. 2023 Jun;21(6):1663-1666.e3. doi: 10.1016/j.cgh.2022.04.026. Epub 2022 May 12.
- Fazio VW, O'Riordain MG, Lavery IC, Church JM, Lau P, Strong SA, Hull T. Long-term functional outcome and quality of life after stapled restorative proctocolectomy. Ann Surg. 1999 Oct;230(4):575-84; discussion 584-6. doi: 10.1097/00000658-199910000-00013.
- Gionchetti P, Morselli C, Rizzello F, et al. Infliximab in the treatment of refractory pouchitis. Gastroenterology 2005;128:A578-A578.
- Kuhbacher T, Ott SJ, Helwig U, Mimura T, Rizzello F, Kleessen B, Gionchetti P, Blaut M, Campieri M, Folsch UR, Kamm MA, Schreiber S. Bacterial and fungal microbiota in relation to probiotic therapy (VSL#3) in pouchitis. Gut. 2006 Jun;55(6):833-41. doi: 10.1136/gut.2005.078303. Epub 2006 Jan 9.
- Kochar B, Martin CF, Kappelman MD, Spiegel BM, Chen W, Sandler RS, Long MD. Evaluation of Gastrointestinal Patient Reported Outcomes Measurement Information System (GI-PROMIS) Symptom Scales in Subjects With Inflammatory Bowel Diseases. Am J Gastroenterol. 2018 Jan;113(1):72-79. doi: 10.1038/ajg.2017.240. Epub 2017 Aug 29.
- Administration FaD. Rifaximin
- Carroll IM, Ringel-Kulka T, Siddle JP, Ringel Y. Alterations in composition and diversity of the intestinal microbiota in patients with diarrhea-predominant irritable bowel syndrome. Neurogastroenterol Motil. 2012 Jun;24(6):521-30, e248. doi: 10.1111/j.1365-2982.2012.01891.x. Epub 2012 Feb 20.
- Carroll IM, Ringel-Kulka T, Keku TO, Chang YH, Packey CD, Sartor RB, Ringel Y. Molecular analysis of the luminal- and mucosal-associated intestinal microbiota in diarrhea-predominant irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2011 Nov;301(5):G799-807. doi: 10.1152/ajpgi.00154.2011. Epub 2011 Jul 7.
- Allali I, Arnold JW, Roach J, Cadenas MB, Butz N, Hassan HM, Koci M, Ballou A, Mendoza M, Ali R, Azcarate-Peril MA. A comparison of sequencing platforms and bioinformatics pipelines for compositional analysis of the gut microbiome. BMC Microbiol. 2017 Sep 13;17(1):194. doi: 10.1186/s12866-017-1101-8.
- Huse SM, Ye Y, Zhou Y, Fodor AA. A core human microbiome as viewed through 16S rRNA sequence clusters. PLoS One. 2012;7(6):e34242. doi: 10.1371/journal.pone.0034242. Epub 2012 Jun 13.
- Kavanagh K, Wylie AT, Tucker KL, Hamp TJ, Gharaibeh RZ, Fodor AA, Cullen JM. Dietary fructose induces endotoxemia and hepatic injury in calorically controlled primates. Am J Clin Nutr. 2013 Aug;98(2):349-57. doi: 10.3945/ajcn.112.057331.
- Sanapareddy N, Legge RM, Jovov B, McCoy A, Burcal L, Araujo-Perez F, Randall TA, Galanko J, Benson A, Sandler RS, Rawls JF, Abdo Z, Fodor AA, Keku TO. Increased rectal microbial richness is associated with the presence of colorectal adenomas in humans. ISME J. 2012 Oct;6(10):1858-68. doi: 10.1038/ismej.2012.43. Epub 2012 May 24.
- Coffey JC, Rowan F, Burke J, Dochery NG, Kirwan WO, O'Connell PR. Pathogenesis of and unifying hypothesis for idiopathic pouchitis. Am J Gastroenterol. 2009 Apr;104(4):1013-23. doi: 10.1038/ajg.2008.127. Epub 2009 Mar 3.
- DuPont HL, Jiang ZD, Okhuysen PC, Ericsson CD, de la Cabada FJ, Ke S, DuPont MW, Martinez-Sandoval F. A randomized, double-blind, placebo-controlled trial of rifaximin to prevent travelers' diarrhea. Ann Intern Med. 2005 May 17;142(10):805-12. doi: 10.7326/0003-4819-142-10-200505170-00005.
- Maharshak N, Cohen NA, Reshef L, Tulchinsky H, Gophna U, Dotan I. Alterations of Enteric Microbiota in Patients with a Normal Ileal Pouch Are Predictive of Pouchitis. J Crohns Colitis. 2017 Mar 1;11(3):314-320. doi: 10.1093/ecco-jcc/jjw157.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juli 2024
Primær fullføring (Antatt)
1. juli 2027
Studiet fullført (Antatt)
1. juli 2027
Datoer for studieregistrering
Først innsendt
8. mars 2024
Først innsendt som oppfylte QC-kriteriene
8. mars 2024
Først lagt ut (Faktiske)
15. mars 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Tarmsykdommer
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Gastroenteritt
- Enteritt
- Ileitt
- Ileal sykdommer
- Pouchitis
- Heterocykliske forbindelser
- Heterocykliske forbindelser, smeltet ringen
- Farmasøytiske preparater
- Doseringsformer
- Polysykliske forbindelser
- Heterocykliske forbindelser, 4 eller flere ringer
- Rifamycins
- Laktams, makrosyklisk
- Makrosykliske forbindelser
- Rifaximin
- Tabletter
Andre studie-ID-numre
- 23-2111
- R03DK140415 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Avidentifiserte individuelle data som støtter resultatene vil bli delt fra 9 til 12 måneder etter publisering, forutsatt at etterforskeren som foreslår å bruke dataene har godkjenning fra en Institutional Review Board (IRB), Independent Ethics Committee (IEC) eller Research Ethics Board (REB) ), som er aktuelt, og utfører en databruks-/delingsavtale med UNC.
IPD-delingstidsramme
begynner 9 og fortsetter i 12 måneder etter publisering
Tilgangskriterier for IPD-deling
Etterforsker har godkjent IRB, IEC eller REB og en inngått avtale om bruk/deling av data med UNC.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .