Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis: A Double-blind, Randomized Placebo-controlled Pilot Study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 45

Inclusion Criteria

Clinical activity index <= 4
Long-standing extensive or left-sided* ulcerative colitis for more than 8 years
Age 18-65 years
Using 6-mercaptopurine or azathioprine to maintain remission
For women only: sufficient anti-conception
Signed informed consent
* added referring to updated guidelines for CRC screening in UC patients (Cairns et al., Gut 2010;59:666-89) and data demonstrating association between inflammation and risk of neoplasia.

Exclusion Criteria

- Dysplasia or colorectal cancer before study entry
- Coexistent liver disease (Primary Sclerosing Cholangitis (PSC), chronic hepatitis B or C infection)
- Colectomy
- Family history of colorectal cancer
- Symptomatic cholelithiasis
- Cholecystitis
- Coagulation disorder or use anticoagulants that can not be temporarily discontinued, precluding the taking of biopsies
- Chronic renal impairment/failure
- Diabetes mellitus (higher risk for developing renal disease)
- Hypertension (higher risk for developing renal disease)
- Allergy to 5-ASA or UDCA
- Vertricular/gastric or duodenal ulcera
- Asthma
- For women only: Pregnancy, lactation or childbearing potential without adequate contraception
- Galactose-intolerance, Lapp lactasedeficience or glucose-galactose malabsorption
- Treatment with antacids containing hydroxide, hypolipidemics, high-dose calcium supplements (>= 1200 mg/day), or any other medication disturbing the enterohepatic circulation
- Treatment with methotrexate, riphampicine, lactulose or glucocorticosteroids.
- Unwillingness to be informed about accidental diagnostic findings

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Study the chemopreventive potential of 5-ASA and UDCA in UC by evaluating<br /><br>the effect of treatment on ACF number, relative to the placebo group.<br /><br>2) Gain mechanistic insight into the chemopreventive properties of 5-ASA and<br /><br>UDCA by genome-wide array based mRNA expression analysis of UC normal colonic<br /><br>mucosa before and after treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Study the chemopreventive potential of 5-ASA and UDCA in UC by evaluating<br /><br>the effect of treatment on ACF size and rate of dysplasia, relative to the<br /><br>placebo group.<br /><br>2) Improve understanding of early events in colorectal carcinogenesis by<br /><br>genome-wide array based mRNA expression analysis of dysplastic ACF and UC<br /><br>normal colonic mucosa.</p><br>