Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch
NCT ID: NCT06864403
Last Updated: 2026-01-30
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
PHASE4
Total Enrollment
25 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-08-12
Study Completion Date
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The goal of this clinical trial is to learn if mirikizumab works to treat pouch disorders in adults. The main questions it aims to answer are:
Does mirikizumab reduce symptoms of pouch disorders
Participants will:
Take mirikizumab every 4 weeks for one year Visit the clinic once every month for two months and at the end of the study Keep a diary of their symptoms
Does mirikizumab reduce symptoms of pouch disorders
Participants will:
Take mirikizumab every 4 weeks for one year Visit the clinic once every month for two months and at the end of the study Keep a diary of their symptoms
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Mirikizumab (LY3074828) Injection in Healthy Participants
NCT03053622
Healthy
COMPLETED
PHASE1
Study of Ixekizumab in Healthy Participants
NCT03848403
Healthy
TERMINATED
PHASE1
A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants
NCT05515601
Healthy
COMPLETED
PHASE1
A Study of Ixekizumab in Healthy Participants
NCT03848416
Healthy
COMPLETED
PHASE1
A Study of Two Formulations of Ixekizumab in Healthy Participants
NCT04259346
Healthy
COMPLETED
PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Pouchitis
Pouches, Ileoanal
Pouch, Ileal
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Interventional Study, open-label real-world observational study
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
All patients
Open Label Mirikizumab
Group Type
OTHER
Mirikizumab - Intravenous (IV)
Intervention Type
DRUG
300 mg mirikizumab at Weeks 0, 4, and 8
Mirikizumab - Subcutaneous (SC)
Intervention Type
DRUG
Pre-filled syringes administered at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mirikizumab - Intravenous (IV)
300 mg mirikizumab at Weeks 0, 4, and 8
Intervention Type
DRUG
Mirikizumab - Subcutaneous (SC)
Pre-filled syringes administered at Weeks 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52.
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Omvoh
Omvoh
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Informed consent will be obtained before any study-related procedures
* Age \>/= 18 and \</= 80 years
* Diagnosis of Chronic Pouchitis or Crohn's-like disease of the pouch based on the following criteria:
* Chronic Antibiotic-Dependent Pouchitis: Recurrent symptoms of pouchitis (frequency, urgency, bleeding, abdominal pain or cramping, or pelvic discomfort) that respond to antibiotic therapy but relapse shortly after stopping antibiotics, thus necessitating continuous antibiotic therapy to achieve symptom control.
* Chronic Antibiotic Refractory Pouchitis: Lack of response to standard antibiotic therapy, requirement of a longer duration of antibiotic therapy than expected with minimal improvement in symptoms, in association with typical symptoms of pouchitis (frequency, urgency, bleeding, abdominal pain or cramping, or pelvic discomfort).
* Crohn's-like disease of the pouch: Presence of a perianal or other fistula that developed at least 12 months after the final stage of Ileal Pouch Anal Anastomosis (IPAA) surgery, stricture of the pouch body or pre-pouch ileum, or the presence of pre-pouch ileitis. Pouch body inflammation (pouchitis) may often coexist in the setting of Crohn's-like disease of the pouch.
* Participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage IPAA and ileostomy takedown
* Ability to access internet for electronic database entry
* Only those individuals for whom a provider is considering initiating mirikizumab for the treatment of chronic pouchitis or Crohn's-like disease of the pouch will be eligible for participation.
* Age \>/= 18 and \</= 80 years
* Diagnosis of Chronic Pouchitis or Crohn's-like disease of the pouch based on the following criteria:
* Chronic Antibiotic-Dependent Pouchitis: Recurrent symptoms of pouchitis (frequency, urgency, bleeding, abdominal pain or cramping, or pelvic discomfort) that respond to antibiotic therapy but relapse shortly after stopping antibiotics, thus necessitating continuous antibiotic therapy to achieve symptom control.
* Chronic Antibiotic Refractory Pouchitis: Lack of response to standard antibiotic therapy, requirement of a longer duration of antibiotic therapy than expected with minimal improvement in symptoms, in association with typical symptoms of pouchitis (frequency, urgency, bleeding, abdominal pain or cramping, or pelvic discomfort).
* Crohn's-like disease of the pouch: Presence of a perianal or other fistula that developed at least 12 months after the final stage of Ileal Pouch Anal Anastomosis (IPAA) surgery, stricture of the pouch body or pre-pouch ileum, or the presence of pre-pouch ileitis. Pouch body inflammation (pouchitis) may often coexist in the setting of Crohn's-like disease of the pouch.
* Participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage IPAA and ileostomy takedown
* Ability to access internet for electronic database entry
* Only those individuals for whom a provider is considering initiating mirikizumab for the treatment of chronic pouchitis or Crohn's-like disease of the pouch will be eligible for participation.
Exclusion Criteria
* Prior exposure to mirikizumab
* Known hypersensitivity to mirikizumab or its metabolites
* Current infection with Clostridioides difficile
* Known HIV or active Hepatitis B/C
* Clinically significant liver disease (Primary Sclerosing Cholangitis with LFT's \<1.5 upper limit of normal can be included)
* Severe hepatic impairment, defined as Child-Pugh Class C
* Known decreased kidney function with a glomerular filtration rate \<45 ml/min/1.732
* History of malignancy, except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years prior to screening and no recurrence.
* Clinically significant laboratory results at screening or baseline, as judged by the Investigator from local testing.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.
* Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
* Known hypersensitivity to mirikizumab or its metabolites
* Current infection with Clostridioides difficile
* Known HIV or active Hepatitis B/C
* Clinically significant liver disease (Primary Sclerosing Cholangitis with LFT's \<1.5 upper limit of normal can be included)
* Severe hepatic impairment, defined as Child-Pugh Class C
* Known decreased kidney function with a glomerular filtration rate \<45 ml/min/1.732
* History of malignancy, except for basal cell carcinoma, non-metastatic squamous cell carcinoma of the skin, or prior malignancy with curative therapy completed at least 5 years prior to screening and no recurrence.
* Clinically significant laboratory results at screening or baseline, as judged by the Investigator from local testing.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.
* Any disorder, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Sponsor Role
collaborator
University of North Carolina, Chapel Hill
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Edward Barnes, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UCLA Vatche & Tamar Manoukian Division of Digestive Diseases
Los Angeles, California, United States
Site Status
RECRUITING
Mayo Clinic
Rochester, Minnesota, United States
Site Status
RECRUITING
NYU Langone Health
New York, New York, United States
Site Status
RECRUITING
University of North Carolina
Chapel Hill, North Carolina, United States
Site Status
RECRUITING
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Site Status
NOT_YET_RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Weaver KN, Gregory M, Syal G, Hoversten P, Hicks SB, Patel D, Christophi G, Beniwal-Patel P, Isaacs KL, Raffals L, Deepak P, Herfarth HH, Barnes EL. Ustekinumab Is Effective for the Treatment of Crohn's Disease of the Pouch in a Multicenter Cohort. Inflamm Bowel Dis. 2019 Mar 14;25(4):767-774. doi: 10.1093/ibd/izy302.
Reference Type
BACKGROUND
Gregory M, Weaver KN, Hoversten P, Hicks SB, Patel D, Ciorba MA, Gutierrez AM, Beniwal-Patel P, Palam S, Syal G, Herfarth HH, Christophi G, Raffals L, Barnes EL, Deepak P. Efficacy of Vedolizumab for Refractory Pouchitis of the Ileo-anal Pouch: Results From a Multicenter US Cohort. Inflamm Bowel Dis. 2019 Aug 20;25(9):1569-1576. doi: 10.1093/ibd/izz030.
Reference Type
BACKGROUND
Ollech JE, Rubin DT, Glick L, Weisshof R, El Jurdi K, Israel A, Krugliak Cleveland N, Hyman N, Sakuraba A, Pekow J, Cohen RD, Dalal SR. Ustekinumab Is Effective for the Treatment of Chronic Antibiotic-Refractory Pouchitis. Dig Dis Sci. 2019 Dec;64(12):3596-3601. doi: 10.1007/s10620-019-05697-1. Epub 2019 Jun 11.
Reference Type
BACKGROUND
Akiyama S, Cohen NA, Kayal M, Dubinsky MC, Colombel JF, Rubin DT. Treatment of Chronic Inflammatory Pouch Conditions With Tofacitinib: A Case Series From 2 Tertiary IBD Centers in the United States. Inflamm Bowel Dis. 2023 Sep 1;29(9):1504-1507. doi: 10.1093/ibd/izad011. No abstract available.
Reference Type
BACKGROUND
Kayal M, Lambin T, Plietz M, Rizvi A, Radcliffe M, Khaitov S, Sylla P, Greenstein AJ, Colombel JF, Dubinsky MC, Ungaro RC. Recycling of Precolectomy Anti-Tumor Necrosis Factor Agents in Chronic Pouch Inflammation Is Associated With Treatment Failure. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1491-1493.e3. doi: 10.1016/j.cgh.2020.07.008. Epub 2020 Jul 12.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Dubinsky MC, Irving PM, Panaccione R, Naegeli AN, Potts-Bleakman A, Arora V, Shan M, Travis S. Incorporating patient experience into drug development for ulcerative colitis: development of the Urgency Numeric Rating Scale, a patient-reported outcome measure to assess bowel urgency in adults. J Patient Rep Outcomes. 2022 Apr 1;6(1):31. doi: 10.1186/s41687-022-00439-w.
Reference Type
BACKGROUND
Yamamoto T, Shimoyama T, Bamba T, Matsumoto K. Consecutive Monitoring of Fecal Calprotectin and Lactoferrin for the Early Diagnosis and Prediction of Pouchitis after Restorative Proctocolectomy for Ulcerative Colitis. Am J Gastroenterol. 2015 Jun;110(6):881-7. doi: 10.1038/ajg.2015.129. Epub 2015 Apr 28.
Reference Type
BACKGROUND
Lin JF, Chen JM, Zuo JH, Yu A, Xiao ZJ, Deng FH, Nie B, Jiang B. Meta-analysis: fecal calprotectin for assessment of inflammatory bowel disease activity. Inflamm Bowel Dis. 2014 Aug;20(8):1407-15. doi: 10.1097/MIB.0000000000000057.
Reference Type
BACKGROUND
Ollech JE, Bannon L, Maharshak N, Bar N, Goren I, Tulchinsky H, Yanai H, Dotan I. Fecal Calprotectin Is Increased in Pouchitis and Progressively Increases With More Severe Endoscopic and Histologic Disease. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1839-1846.e2. doi: 10.1016/j.cgh.2021.11.012. Epub 2021 Nov 16.
Reference Type
BACKGROUND
Singh S, Ananthakrishnan AN, Nguyen NH, Cohen BL, Velayos FS, Weiss JM, Sultan S, Siddique SM, Adler J, Chachu KA; AGA Clinical Guidelines Committee. Electronic address: [email protected]. AGA Clinical Practice Guideline on the Role of Biomarkers for the Management of Ulcerative Colitis. Gastroenterology. 2023 Mar;164(3):344-372. doi: 10.1053/j.gastro.2022.12.007.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
D'Haens G, Dubinsky M, Kobayashi T, Irving PM, Howaldt S, Pokrotnieks J, Krueger K, Laskowski J, Li X, Lissoos T, Milata J, Morris N, Arora V, Milch C, Sandborn W, Sands BE; LUCENT Study Group. Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2023 Jun 29;388(26):2444-2455. doi: 10.1056/NEJMoa2207940.
Reference Type
BACKGROUND
Sands BE, D'Haens G, Clemow DB, Irving PM, Johns JT, Hunter Gibble T, Abreu MT, Lee S, Hisamatsu T, Kobayashi T, Dubinsky MC, Vermeire S, Siegel CA, Peyrin-Biroulet L, Moses RE, Milata J, Arora V, Panaccione R, Dignass A. Two-Year Efficacy and Safety of Mirikizumab Following 104 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study. Inflamm Bowel Dis. 2024 Dec 5;30(12):2245-2258. doi: 10.1093/ibd/izae024.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Barnes EL, Agrawal M, Syal G, Ananthakrishnan AN, Cohen BL, Haydek JP, Al Kazzi ES, Eisenstein S, Hashash JG, Sultan SS, Raffals LE, Singh S; AGA Clinical Guidelines Committee. Electronic address: [email protected]. AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders. Gastroenterology. 2024 Jan;166(1):59-85. doi: 10.1053/j.gastro.2023.10.015.
Reference Type
BACKGROUND
Kayal M, Deepak P, Beniwal-Patel P, Raffals L, Dubinsky M, Chang S, Higgins PDR, Jiang Y, Cross RK, Long MD, Herfarth HH, Barnes EL. Changes in Therapy Are Not Associated With Increased Remission in Patients With Crohn's Disease of the Pouch. Am J Gastroenterol. 2024 Mar 1;119(3):584-587. doi: 10.14309/ajg.0000000000002599. Epub 2023 Nov 17.
Reference Type
BACKGROUND
Barnes EL, Deepak P, Beniwal-Patel P, Raffals L, Kayal M, Dubinsky M, Chang S, Higgins PDR, Barr JI, Galanko J, Jiang Y, Cross RK, Long MD, Herfarth HH. Treatment Patterns and Standardized Outcome Assessments Among Patients With Inflammatory Conditions of the Pouch in a Prospective Multicenter Registry. Crohns Colitis 360. 2022 Aug 2;4(3):otac030. doi: 10.1093/crocol/otac030. eCollection 2022 Jul.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Travis S, Silverberg MS, Danese S, Gionchetti P, Lowenberg M, Jairath V, Feagan BG, Bressler B, Ferrante M, Hart A, Lindner D, Escher A, Jones S, Shen B; EARNEST Study Group. Vedolizumab for the Treatment of Chronic Pouchitis. N Engl J Med. 2023 Mar 30;388(13):1191-1200. doi: 10.1056/NEJMoa2208450.
Reference Type
BACKGROUND
Chandan S, Mohan BP, Kumar A, Khan SR, Chandan OC, Kassab LL, Ponnada S, Kochhar GS. Safety and Efficacy of Biological Therapy in Chronic Antibiotic Refractory Pouchitis: A Systematic Review With Meta-analysis. J Clin Gastroenterol. 2021 Jul 1;55(6):481-491. doi: 10.1097/MCG.0000000000001550.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Feagan BG, Hibi T, Tuttle JL, Klekotka P, Friedrich S, Durante M, Morgan-Cox M, Laskowski J, Schmitz J, D'Haens GR. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):537-549.e10. doi: 10.1053/j.gastro.2019.08.043. Epub 2019 Sep 4.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Gionchetti P, Morselli C, Rizzello F, et al. Infliximab in the treatment of refractory pouchitis. Gastroenterology 2005;128:A578-A578
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Barnes EL, Boynton MH, DeWalt DA, Herfarth HH, Kappelman MD. Patient Reported Outcome Assessments Used in the Evaluation of Patients after Ileal Pouch-Anal Anastomosis: A Systematic Review. Gastro Hep Adv. 2023;2(8):1044-1049. doi: 10.1016/j.gastha.2023.07.010. Epub 2023 Jul 29.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Dubinsky MC, Panaccione R, Lewis JD, Sands BE, Hibi T, Lee SD, Naegeli AN, Shan M, Green LA, Morris N, Arora V, Bleakman AP, Belin R, Travis S. Impact of Bowel Urgency on Quality of Life and Clinical Outcomes in Patients With Ulcerative Colitis. Crohns Colitis 360. 2022 Jun 3;4(3):otac016. doi: 10.1093/crocol/otac016. eCollection 2022 Jul.
Reference Type
BACKGROUND
Barnes EL. A Practical Guide to the Use of Mirikizumab. Am J Gastroenterol. 2024 Mar 1;119(3):400-403. doi: 10.14309/ajg.0000000000002531. Epub 2023 Oct 2. No abstract available.
Reference Type
BACKGROUND
European Medicines Agency: Vedolizumab.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24-2214
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Ixekizumab in the Treatment of Bullous Pemphigoid
NCT03099538
COMPLETED
PHASE2
A 44-week Monocentric Open Study Assessing the Efficacy and Safety of Deucravacitinib in Adults With Inflammatory Genodermatoses
NCT06136403
RECRUITING
PHASE2
Healthy-donor Microbiome MTP-101-C in Steroid Relapse/Refractory Immune-related Cutaneous Adverse Events (irCAEs) and Immune-mediated Colitis (IMC)
NCT06499896
RECRUITING
PHASE2
CardiolRx in Recurrent Pericarditis Following IL-1 Blocker Cessation
NCT06708299
RECRUITING
PHASE3
A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants
NCT04840901
COMPLETED
PHASE1
A Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants
NCT06243198
COMPLETED
PHASE1
Use of Infliximab for the Treatment of Pemphigus Vulgaris
NCT00283712
COMPLETED
PHASE2
Safety and Effectiveness of h5G1.1-mAb for Dermatomyositis
NCT00005571
COMPLETED
PHASE2
A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
NCT02020889
COMPLETED
PHASE3
A Study to Assess Subcutaneous AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis
NCT05152563
WITHDRAWN
PHASE3
Dupilumab in Eosinophilic Gastritis
NCT03678545
COMPLETED
PHASE2
A Study of LY3463251 in Healthy Participants
NCT03764774
TERMINATED
PHASE1
A Single-Dose Study of LY3471851 in Healthy Participants
NCT04998487
COMPLETED
PHASE1
A Trial of Baricitinib in Patients With Cardiac Sarcoidosis
NCT06868381
NOT_YET_RECRUITING
PHASE2
Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis
NCT04438382
TERMINATED
PHASE2
Study of Belimumab Administered Subcutaneously to Healthy Subjects
NCT01583530
COMPLETED
PHASE1
Part B- G1X-CGD (Lentiviral Vector Transduced CD34+ Cells) in Patients With X-Linked Chronic Granulomatous Disease
NCT07113743
ENROLLING_BY_INVITATION
PHASE1/PHASE2
Study of Deucravacitinib for Refractory Adults With Dermatomyositis/Juvenile Dermatomyositis
NCT07012057
WITHDRAWN
PHASE2
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB2 in Healthy Subjects
NCT01922336
COMPLETED
PHASE1
Use of KC706 for the Treatment of Pemphigus Vulgaris
NCT00606749
COMPLETED
PHASE2
Ixekizumab in the Treatment of Pityriasis Rubra Pilaris (PRP)
NCT03485976
COMPLETED
PHASE2
A Study of Infliximab in Patients With Sarcoidosis
NCT00073437
COMPLETED
PHASE3
The Effects of Tildrakizumab in Treatment of Bullous Pemphigoid
NCT04465292
UNKNOWN
EARLY_PHASE1
A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis)
NCT04322604
COMPLETED
PHASE3
UCB Proof of Concept Study in Patients With Primary Sjögren's Syndrome
NCT02610543
TERMINATED
PHASE2