Biological therapy for pouches
Research type
Research Study
Full title
Biological therapy as a rescue therapy for a troubled pouch: A multi-centre experience
IRAS ID
233311
Contact name
Jonathan Segal
Contact email
Sponsor organisation
London North West Healthcare NHS Trust
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
Ulcerative colitis is an idiopathic chronic inflammatory disorder of the colon that has a relapsing remitting pattern. It is the most common type of inflammatory disease of the bowel, with an incidence of 10 per 100,000 people annually, and a prevalence of 243 per 100,000.
About half of patients with ulcerative colitis require surgery. One of the surgical options is restorative proctocolectomy (RPC) with ileal pouch anal anastomosis, which is considered the procedure of choice in patients with ulcerative colitis (UC) refractory to medical therapy. The procedure removes a diseased large bowel and uses the patient’s own small bowel as a reservoir for faeces. This is often therefore considered the procedure of choice for patients with refractory UC as it avoids the need for a stoma (bag). Despite functional outcomes generally reported as good, complications such as pouchitis can arise. Pouchitis is an inflammation of the pouch and can cause symptoms such as increased stool frequency, pain, bleeding and overall poor quality of life. The incidence of acute pouchitis is 20% at one year and up to 40% at five years following surgery. Chronic pouchitis develops in approximately 10–15% of patients with acute pouchitis.
Infliximab is a biological drug that has been used in Crohn's disease and Ulcerative colitis since 2008. Its role in pouchitis has been poorly studied as it is usually a last line therapy. As pouchitis itself is a rare condition it means that little is known about the safety and efficacy of this drug.
This study will build upon the available literature and highlight the effect biological therapy has on treating pouchitis. By using a multi-centre study we will be able to gather greater numbers and therefore aid our understanding on the effect Anti-TNF therapy has on pouchitis patients.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/1606
Date of REC Opinion
18 Sep 2017
REC opinion
Favourable Opinion