'inflammatory bowel disease' 'ulcerative colitis'
Conditions
Interventions
Colitis
Mesalazine
Therapeutic drug monitoring
Ulcerative
Sponsors
Maag, darm, leverziekten
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to participate in this study, a subject must meet all of the following criteria: - Patients >18 year old with established ulcerative colitis in care in the UMC Utrecht - Indication for an endoscopy (diagnostic endoscopy during a flare or regular surveillance endoscopy during clinical remission; colonoscopy or sigmoidoscopy) - Using an oral 5-ASA formulation (except a prodrug) per day for at least two weeks in a dose of 2.0 until 3,0 gram/day during active disease (thus endoscopy for flare) or 2.0 until 4.8 gram/day during remission (endoscopy for surveillance)
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Previous intestinal surgery (with the exception of appendectomy) - Need for surgical interventions - Active use of laxatives (bisacodyl, poly ethyleen glycol / Pegol) or anti-diarrheal mediation (opioids, codeine, loperamide) - Combination use with other 5-ASA formulations (enema, suppository) - Pregnancy - Stool frequency less than 1 time a day (slow intestinal transit time) - Uncontrolled or sever liver, renal, cardiac or pulmonary disease: o Liver: Child-Pugh score > 7 o Renal: GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Included patients will be divided in two groups: active disease and clinical remission. Patients will start collected urine and faeces (for 1 and 3 days, respectively) 5 days before endoscopy. During endoscopy mucosal biopsies will be collected. The 5-ASA and N-Ac-5-ASA concentration will be determined using quantitative HPLC analysis. The main study parameters/endpoints include: 5-ASA concentration in faeces, expressed in mgs in patients with active and quiescent disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| - faecal excretion of 5-ASA in 24-hours faeces expressed in % of ingested dose - faecal excretion of 5-ASA in 24-hours faeces expressed correlation to dry weight - faecal N-Ac-5-ASA concentration in 24-hours faeces expressed in % and mg and in relation to dry weight - mucosal 5-ASA and N-Ac-5-ASA concentration in colonic biopsies expressed in ng/mg - 5-ASA and N-Ac-5-ASA concentration in 24 hours urine expressed in % and mg - composition of gut microbiome All in patients with active and quiescent disease ulcerative colitis | — |
Countries
The Netherlands
Outcome results
None listed