Rifaximin for the Secondary Prevention of Recurrent Pouchitis

Обзор

Although many people will develop recurrent pouchitis (inflammation of the ileal pouch-anal anastomosis or J-pouch after colectomy for ulcerative colitis) after an initial episode of pouchitis, there are currently no effective treatments to prevent recurrent pouchitis. The goal of this study is to evaluate the potential for rifaximin, an antibiotic, to prevent recurrent pouchitis after treatment for an initial episode of pouchitis. In this study, all patients will be given daily rifaximin for one year after being treated for an initial episode of pouchitis. This study will examine whether people are willing to take rifaximin for one year with the goal of preventing recurrent pouchitis. Additionally, this study will examine whether patients experience any unexpected side effects of rifaximin therapy. The information gained through this study will potentially be helpful in improving the ability to prevent recurrent pouchitis in patients who have a colectomy for ulcerative colitis.

Вмешательства

• Препарат Rifaximin 550 MG Oral Tablet [XIFAXAN]
  Rifaximin 550 MG Oral Tablet \[XIFAXAN\] Taken twice a day for up to 365 days

Первичные конечные точки

• Percentage of Participants Who Develop Recurrent Pouchitis [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Informed consent will be obtained before any study-related procedures
• Age > 18 and <75 years
• Participants with a proven history of ulcerative colitis and history of 1,2, modified -2 or 3 stage Ileal pouch anal anastomosis (IPAA) and ileostomy takedown
• Diagnosis of initial episode of pouchitis within the first 12 months after ileostomy takedown/final stage of IPAA surgery

Критерии исключения

• Known hypersensitivity to rifaximin or its metabolites
• Known Crohn's disease
• History of perianal fistula
• Known incontinence due to anal sphincter dysfunction
• Known irritable pouch syndrome
• Active ongoing pelvic infection/sepsis at baseline visit
• New onset of high bowel frequency in the setting of acute pouchitis in the first 4 weeks after IPAA
• Known Clostridoides difficile infection
• Need for antibiotic long-term therapy (e.g. doxycycline for acne)
• Known active Hepatitis B, C, HIV
• 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
• Concomitant use of p-glycoprotein (P-gp) inhibitors (e.g. cyclosporine)
• Known decreased kidney function with a glomerular filtration rate <60 ml/min/1.732
• Fecal microbiota transplantation within 16 weeks before ileostomy takedown
• 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. Women of child-bearing potential must have a negative urine pregnancy test prior to drug being dispensed.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 2 центра

• NYU IBD Center — New York
• University of North Carolina — Chapel Hill

Публикации

• 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. PMID 25222665
• 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. PMID 12730861
• 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. PMID 28301429
• 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. PMID 28426474
• 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. PMID 31634390
• 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. PMID 32585362
• 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. PMID 31596761
• 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. PMID 35525393

Идентификаторы

NCT: NCT06312683 · 23-2111 · R03DK140415

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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