Study:
n/a
Rationale:
n/a
Purpose:
Total proctocolectomy and ileal pouch-anal anastomosis is the surgical treatment of choice
for patients with medically refractory ulcerative colitis, ulcerative colitis with dysplasia
or cancer, and patients with familial adenomatous polyposis. Pouchitis, an inflammatory
process of the ileal pouch, is the most common long-term complication. Increased stool
frequency, abdominal pain, and pelvic discomfort are suggestive of pouchitis, approximately
40% of patients with these symptoms have no or minimal inflammation of the pouch or rectal
cuff on endoscopy and histopathology. These patients have a condition resembling irritable
bowel syndrome (IBS), which we termed the irritable pouch syndrome (IPS). The RATIONALE and
FEASIBILITY for the proposed study are: 1) IPS occurs in a substantial number of patients
with IPAA, significantly affecting the quality of life. However, IPS is rare in the general
population, and is considered an orphan disease. Studies such as those we propose can only
be conducted in centers with a large number of patients with IPAA. The Cleveland Clinic has
maintained the world`s largest ileal pouch registry, with a total of more the 2,500
patients; 2) a series of investigations on the diagnosis and treatment of patients with
inflammatory or functional diseases of IPS, notably the initial study of IPS, have been
conducted by our team; 3) In contrast to IBS, the pathophysiology and treatment of IPS have
not been studied. Our HYPOTHESES are that 1) similar to IBS, visceral hypersensitivity may
play a role in the pathogenesis of IPS, and 2) amitriptyline, a safe and effective agent for
patients with IBS, will be more effective than placebo in alleviating symptoms and improving
quality of life in patients with IPS. The AIMS of the study are to 1) investigate visceral
hypersensitivity using barostat examination of the pouch; 2) conduct a randomized,
placebo-controlled clinical trial evaluating the use of amitriptyline in IPS.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Pouchitis |
Procedure: Electronic Barostat |
Phase 3 |
Verified by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March, 2010
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov identifier: NCT00293553
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Bo Shen, M.D.., Principal Investigator