June 11, 2015
Below are current clinical trials.4 studies in Pouchitis
(open studies only).
Filter this list of studies by location, status and more.
The purpose of this study is to assess the effectiveness and safety of vedolizumab intravenous (IV) in patients who have a proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have developed chronic or recurrent pouchitis, or require continuous antibiotic treatment.
A Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic antibiotic refractory pouchitis. Subjects will undertake a <2 week screening period to provide baseline data and be assessed for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1 basis to either a) 240 mg alicaforsen enema or b) matching placebo. Study drug will be administered once nightly (on going to bed) up to and including week 6. Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy assessments at Week 3, 6, 10, 18 and 26. Subjects may receive certain permitted medications as per Entry Criteria, which must remain at stable doses throughout the trial. Introduction of any new medication for pouchitis, or a dose change to an existing concomitant medication for pouchitis, other than those detailed in the protocol, will not be permitted. Clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary card. Subjects will undergo endoscopic examination of their pouch (during Screening, and at Weeks 6 and 10). Where technically feasible, each endoscopy will provide at least one biopsy sample for histopathology. In addition to endoscopic, histopathologic and symptomatic assessments, Quality of Life will be assessed. Bloods for routine assessment, including haematology and biochemistry will be taken. Bloods and stool samples will be collected to evaluate relevant biomarkers.
The purpose of this study is to find out if there is a relationship between pouch function (the ability to completely evacuate or empty the pouch) and the development of inflammation in the pouch.
The purpose of this study is to learn more about the bacteria that live in the small and large intestine and the role that these bacteria play in causing inflammation in the gastrointestinal tract.
- Chowdhry S, et al. Update on the pathogenesis and management of pouchitis. Current Infectious Disease Reports. 2014;16:442.
- Feldman, M, et al. Ileostomy, colostomy, and pouches. In: Sleisenger and Fordtran's Gastrointestinal and Liver Disease: Pathophysiology, Diagnosis, Management. 10th ed. Philadelphia, Pa.: Saunders Elsevier; 2016. https://www.clinicalkey.com. Accessed April 9, 2015.
- Batista D, et al. Role of intestinal bacteria in the pathogenesis of pouchitis. Inflammatory Bowel Diseases. 2014;20:1481.
- Shen B. Pouchitis: Epidemiology, clinical manifestations, and diagnosis. http://www.uptodate.com/home. Accessed April 9, 2015.
- Shen B. Pouchitis: Management. http://www.uptodate.com/home. Accessed April 9, 2015.
- Corticosteroids. Crohn's & Colitis Foundation of America. http://www.ccfa.org/resources/corticosteroids.html. Accessed April 13, 2015.
- Golden AK. Decision Support System. Mayo Clinic, Rochester, Minn. April 9, 2015.