- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00293553
Clinical Approaches to Ileal Pouch Dysfunction
March 17, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Overview
Study Type
Interventional
Enrollment (Anticipated)
64
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:(must meet ALL of the following criteria);
- Having a history of UC and more than 1 year from TPC/IPAA
- Meet diagnostic criteria of IPS, i.e.
- Symptoms of diarrhea and abdominal pain, with PDAI symptoms score > (range 2-6).
- Duration of symptoms > 12 weeks in the preceding 12-months period
- Pouch endoscopy shows no evidence of inflammation of the ileal pouch and rectal cuff
- No antibiotic therapy, aspirin, or non-steriodal anti-inflammatory drugs for 2 weeks prior to entry into the study; no antidepressant and or anti-anxiety medicines for at least 4 weeks.
Exclusion Criteria:(may meet ANY of the following criteria);
- A history of development of side effects from amitriptyline
- IPAA for FAP; celiac disease; chronic pouchitis; Crohn's disease; pouch stricture or anastomotic leak
- Urinary retention, glaucoma, use of MAO inhibitors within past 14 days; acute recovery phase following myocardial infarction; pregnancy
- Psychiatric disorder, including major depression, which requires medical therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bo Shen, M.D., The Cleveland Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion (Actual)
December 1, 2007
Study Registration Dates
First Submitted
February 16, 2006
First Submitted That Met QC Criteria
February 16, 2006
First Posted (Estimate)
February 17, 2006
Study Record Updates
Last Update Posted (Estimate)
March 18, 2010
Last Update Submitted That Met QC Criteria
March 17, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R03 DK67275 (completed 2007)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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