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

Phase 2

Withdrawn

• Conditions: Inflammatory bowel disease; ulcerative colitis; 10017969; 10017991

• Registration Number: NL-OMON31889
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 45

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Difference in effect of treatment with a-ASA or 5-ASA ánd UDCA on the total<br /><br>number of ACF compared to the placebo-group.<br /><br>2) Difference in mRNA-expression in normal colon mucosa before and after<br /><br>treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Difference in effect of treatment with 5-ASA or 5-ASA ánd UDCA on ACF size<br /><br>and rate of dysplasia compared to the placebo-group.<br /><br>2) Difference in mRNA-expression in dysplastic ACF and normal colon mucosa in<br /><br>UC patients.</p><br>