17 completed, 10 unknown, 7 recruiting, 7 terminated. 15 Phase 2, 12 Not applicable, 7 Phase 3, 6 Phase 1, 6 Phase 4.
Follow Pouchitis: new trials by email Literature Review of Pouchitis trials Research Report on Pouchitis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery 5-ASA, Placebo - Ulcerative Colitis (UC), Pouchitis | Phase 4 | Not yet recruiting | University Hospital, Linkoeping | 110 | 2027-04-01 | 2026-08-19 |
| Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC) MTB-targeted phage therapy - Pouchitis, UC - Ulcerative Colitis | Early Phase 1 | Not yet recruiting | Jinling Hospital, China | 12 | 2027-01-01 | 2026-10-22 |
| Emerging Indications for Hyperbaric Oxygen Treatment Hyperbaric oxygen treatment (HBOT), 100% Oxygen - Post-COVID-19 Condition, Ulcerative Colitis | Phase 4 | Not yet recruiting | Jay C. Buckey Jr. | 100 | 2026-11-01 | 2026-09-09 |
| Etrasimod as Prevention of Pouchitis etrasimod, Placebo - Pouchitis | Phase 2 | Recruiting | Maia Kayal | 40 | 2026-07-01 | 2026-09-21 |
| CLF065 for Chronic Pouchitis CLF065, Placebo - Pouchitis | Phase 2 | Suspended | Calibr, a division of Scripps Research | 20 | 2026-06-01 | 2026-07-09 |
| GUselkumAb inteRvention and DIet evaluAtioN for Pouchitis Guselkumab, Diet - Pouchitis | Phase 4 | Recruiting | Universitaire Ziekenhuizen KU Leuven | 20 | 2026-04-23 | 2026-05-05 |
| Mirikizumab in the Treatment of Chronic Inflammatory Conditions of the Pouch Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC) - Pouchitis, Pouches, Ileoanal | Phase 4 | Recruiting | University of North Carolina, Chapel Hill | 25 | 2025-08-12 | 2026-01-30 |
| Exploring the Influence of Trptophan on the Treatment of Pouchitis Tryptophan 25mg/kg bodyweight, Placebo - Pouchitis | Not applicable | Not yet recruiting | Universitätsklinikum Hamburg-Eppendorf | 20 | 2025-04-01 | 2025-03-06 |
| A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis Vedolizumab, Concomitant Antibiotic Therapy - Pouchitis | Phase 3 | Recruiting | Takeda | 30 | 2024-11-19 | 2026-08-03 |
| Fecal Microbiota Transplant for Patients With Chronic Pouchitis Fecal Microbiota Transplant (FMT) - Chronic Pouchitis, Pouchitis | Early Phase 1 | Recruiting | Maia Kayal | 16 | 2024-10-03 | 2026-08-17 |
| Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis Intestinal Ultrasound - Ulcerative Colitis, Pouchitis | Not applicable | Completed | Mayo Clinic | 66 | 2024-07-01 | 2026-08-12 |
| Rifaximin for the Secondary Prevention of Recurrent Pouchitis Rifaximin 550 MG Oral Tablet [XIFAXAN] - Pouchitis | Phase 4 | Recruiting | University of North Carolina, Chapel Hill | 16 | 2024-07-01 | 2026-10-23 |
| Study of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an IPAA (PROF) EXE-346, Placebo - Ileal Pouch | Phase 1 / Phase 2 | Recruiting | Exegi Pharma, LLC | 50 | 2023-11-06 | 2026-05-28 |
| Stem Cells for the Treatment of Pouchitis Mesenchymal Stem Cells (MSCs) - Pouchitis, Crohn's Disease | Phase 1 | Withdrawn | The Cleveland Clinic | 2022-04-01 | 2026-04-16 | |
| Efficacy of Liraglutide Therapy in Patients With IPAA Liraglutide Pen Injector, Placebo Pen Injector - Pouchitis, Irritable Pouch Syndrome | Phase 2 | Terminated | University of North Carolina, Chapel Hill | 8 | 2022-03-22 | 2024-07-23 |
| Assessment of Patients With Acute Pouchitis Treated With Antibiotics Observational, No intervention - Pouchitis, Ulcerative Colitis | Suspended | Alimentiv Inc. | 43 | 2021-12-07 | 2024-02-20 | |
| GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery GM-CSF, fosfomycin and metronidazole - Pouchitis | Phase 1 / Phase 2 | Unknown | Zealand University Hospital | 18 | 2021-09-06 | 2023-01-26 |
| Faecal Microbiota Transplantation From Normal Pouch Function Donor in the Treatment of Chronic Pouchitis Faecal microbiota transplantation - Pouchitis, Inflammatory Bowel Diseases | Not applicable | Completed | Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery | 3 | 2021-03-01 | 2022-07-13 |
| Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis AMT-101 (oral)-Dose A, AMT-101 (oral)-Dose B - Pouchitis | Phase 2 | Completed | Applied Molecular Transport | 22 | 2021-02-05 | 2022-09-14 |
| Tofacitinib For Treatment Of Chronic Pouchitis Tofacitinib 10 mg - Pouchitis, Ileal Pouchitis | Phase 2 | Terminated | Cedars-Sinai Medical Center | 6 | 2021-01-25 | 2024-04-04 |
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Colitis, Ulcerative (22) · Crohn Disease (7) · Inflammatory Bowel Diseases (6) · Adenomatous Polyposis Coli (2) · Anastomotic Leak (2) · Colorectal Neoplasms (2) · Calciphylaxis (1) · Cholangitis, Sclerosing (1) · Colitis (1) · Craniocerebral Trauma (1) · Enterocolitis, Pseudomembranous (1) · Epidermolysis Bullosa (1) · Frostbite (1) · Graft vs Host Disease (1)
Digestive System Diseases (50) · Enteritis (50) · Gastroenteritis (50) · Gastrointestinal Diseases (50) · Ileal Diseases (50) · Intestinal Diseases (50) · Ileitis (49) · Colonic Diseases (22) · Colitis (21) · Inflammatory Bowel Diseases (17) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (3) · Genetic Diseases, Inborn (3) · Pathologic Processes (3) · Pathological Conditions, Signs and Symptoms (3) · Postoperative Complications (3)
Fecal Microbiota Transplantation (6) · AST 120 (2) · Diet (2) · vedolizumab (2) · Adalimumab (1) · Ciprofloxacin (1) · Clotrimazole (1) · FODMAP Diet (1) · Fosfomycin (1) · Granulocyte-Macrophage Colony-Stimulating Factor (1) · Hyperbaric Oxygenation (1) · Liraglutide (1) · Medical Marijuana (1) · Metronidazole (1) · Oxygen (1)
University of North Carolina, Chapel Hill (4) · Tel-Aviv Sourasky Medical Center (3) · Charite University, Berlin, Germany (2) · Jinling Hospital, China (2) · Maia Kayal (2) · Mayo Clinic (2) · Ocera Therapeutics (2) · Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery (2) · Takeda (2) · Universitaire Ziekenhuizen KU Leuven (2) · Aalborg University Hospital (1) · Alimentiv Inc. (1) · Applied Molecular Transport (1) · Atlantic Pharmaceuticals Ltd (1) · Boston Medical Center (1)
United States (24) · Belgium (6) · Canada (6) · Israel (6) · Denmark (5) · Netherlands (5) · France (4) · Germany (4) · Italy (4) · Spain (3) · United Kingdom (3) · China (2) · Sweden (2) · Switzerland (2) · Croatia (1)
Ole Thorlacius-Ussing, Professor (3) · Edward Barnes, MD, MPH (2) · Hans Herfarth, MD, PhD (2) · A. Masclee, Prof MD PhD (1) · Amy L Lightner, MD (1) · Bo Shen, M.D. (1) · Bo Shen, MD (1) · Carl Brown (1) · Chris Dunk (1) · Darrell Pardi, MD (1) · Darrell S. Pardi, MD (1) · Fangyu Wang (1) · Francis Farraye, MD (1)
PMID 19415309, PMID 21549404, PMID 21601883, PMID 21983950, PMID 25110406, PMID 32493442, PMID 33501942, PMID 36988594, PMID 38668926, PMID 38708959, PMID 38750870, PMID 39025255, PMID 39485259, PMID 42232317, PMID 42728546
2015 (1), 2023 (1), 2025 (1), R03DK067275 (1), R03DK140415 (1)