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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, glucocorticosteroids
- Unwillingness to be informed about accidental diagnostic findings

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Study the chemopreventive potential of 5-aminosalicylic acid (5-ASA) and ursodeoxycholic acid (UDCA) in UC by evaluating the effect of treatment on abberant crypt foci (ACF) number, size and rate of dysplasia. <br><br>;Primary end point(s): 1) Study the chemopreventive potential of 5-ASA and UDCA in UC by evaluating the effect of treatment on ACF number.<br>2) Gain mechanistic insight into the chemopreventive properties of 5-ASA and UDCA by genome-wide array based mRNA expression analysis of UC normal colonic mucosa before and after treatment.<br>;Secondary Objective: 1. Gain mechanistic insight into the chemopreventive properties of 5-ASA and UDCA by genome-wide array based mRNA expression analysis of UC normal colonic mucosa before and after treatment.<br>2. Improve understanding of early events in colorectal carcinogenesis by genome-wide array based mRNA expression analysis of dysplastic ACF and UC normal colonic mucosa.<br>

Secondary Outcome Measures

Name	Time	Method

Related Trials