Inflammatory bowel disease ulcerative colitis
Conditions
Interventions
There will be three groups:
1) This group will receive 5-ASA 4g (4 sachets of 1000mg) a day and UDCA in
tablets of 500mg in a dosage of 20-30 mg/kg a day
2) This group will receive 5-ASA 4g (4 sache
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Clinical activity index * 4 Long-standing extensive 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
Exclusion criteria
Exclusion criteria: - Dysplasia or colorectal cancer before study entry - Coexistent liver disease (Primary Sclerosing Cholangitis, chronic hepatitis B/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, lactuloseor glucocorticosteroids - Unwillingness to be informed about accidental diagnostic findings
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Difference in effect of treatment with a-ASA or 5-ASA ánd UDCA on the total number of ACF compared to the placebo-group. 2) Difference in mRNA-expression in normal colon mucosa before and after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Difference in effect of treatment with 5-ASA or 5-ASA ánd UDCA on ACF size and rate of dysplasia compared to the placebo-group. 2) Difference in mRNA-expression in dysplastic ACF and normal colon mucosa in UC patients. | — |
Countries
Netherlands
Outcome results
None listed