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Pouchitis clinical trials

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NCT ID: NCT06443502 Not yet recruiting - Pouchitis Clinical Trials

A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

Start date: June 25, 2024
Phase: Phase 3
Study type: Interventional

When some people have their large bowel removed, a surgeon can make a "pouch" from part of the small bowel to connect it to the back passage (anus). Pouchitis is when the pouch becomes inflamed (swollen) or infected. The main aim of this study is to find out if vedolizumab improves pouchitis symptoms and pouch inflammation. Other aims include to find out if vedolizumab is well tolerated and if it causes any medical problems (adverse events or side effects) and to look for any changes in the well-being of participants during their treatment with vedolizumab. Participants will receive up to 6 infusions of vedolizumab. First 3 infusions are in first 6 weeks (Day 1, Week 2 and Week 6). Participants who are getting benefit may continue with the treatment for up to 7.5 months (30 weeks) in total. After completing treatment with vedolizumab, participants will visit their clinic for a health check at Week 34. One final health check will be scheduled 4.5 months (18 weeks) after the last vedolizumab infusion. Participants who continue to benefit from their treatment at the end of this study will be invited to continue treatment with vedolizumab in another clinical study (Vedolizumab-3042).

NCT ID: NCT06316999 Not yet recruiting - Ulcerative Colitis Clinical Trials

Intestinal Ultrasound for the Evaluation of Pouchitis and Other Outcomes After Ileal Pouch-Anal Anastomosis

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Intestinal ultrasound (IUS) has been studied in the evaluation of inflammatory bowel disease (IBD) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. However, there is a paucity of data on the use of IUS specifically for ulcerative colitis (UC) patients with an ileal pouch-anal anastomosis (IPAA).

NCT ID: NCT06312683 Not yet recruiting - Pouchitis Clinical Trials

Rifaximin for the Secondary Prevention of Recurrent Pouchitis

Start date: April 2024
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT05829109 Not yet recruiting - Pouchitis Clinical Trials

Fecal Microbiota Transplant for Patients With Chronic Pouchitis

Start date: September 2024
Phase: Early Phase 1
Study type: Interventional

The purpose of this research study is to assess the safety and efficacy of fecal microbiota transplant (FMT) in the treatment of chronic pouchitis.

NCT ID: NCT03526796 Not yet recruiting - Pouchitis Clinical Trials

Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis

HBOT-pouch
Start date: June 1, 2018
Phase: N/A
Study type: Interventional

The aim of current study is to evaluate the effect of hyperbaric oxygen therapy for the treatment of chronic antibiotic-refractory pouchitis.

NCT ID: NCT01202396 Not yet recruiting - Pouchitis Clinical Trials

The Interaction Between Intestinal Microbiota, Innate Defense and Epithelial Integrity in the Development of Pouchitis

Start date: November 2010
Phase: N/A
Study type: Observational

Pouchitis is a common complication following proctocolectomy with ileal pouch anal anastomosis (IPAA) in patients with ulcerative colitis (UC). It affects the quality of life and can become a chronic problem. The aetiology of pouchitis is not completely understood. A crucial role of the intestinal microbiota has been suggested, but no causative agent has been identified so far. Furthermore, the defensin expression and the epithelial integrity are altered in inflammatory bowel diseases and may play an important role in the development of intestinal inflammation. Therefore, it has been hypothesized that the interaction between an altered microbiota composition, a defective epithelial integrity and changes in innate defense parameters such as defensins has a pivotal role in the development of pouchitis in UC patients.