Exploring the role of faecal mesalazine (5-ASA) concentrations in therapeutic drug monitoring in ulcerative colitis: a pilot study.

Completed

Conditions: 'inflammatory bowel disease'
'ulcerative colitis'
10017969

Registration Number: NL-OMON48827

Lead Sponsor: Maag, darm, leverziekten

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 28

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

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 < 60 ml/min for more than 3 months
o Pulmonal: COPD GOLD stage 3-4, need of oxygen supply at home, or uncontrolled asthma
o Cardiac: heart failure NYHA class 3-4 or myocardial infarct in the past 12 months

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Included patients will be divided in two groups: active disease and clinical<br /><br>remission. Patients will start collected urine and faeces (for 1 and 3 days,<br /><br>respectively) 5 days before endoscopy. During endoscopy mucosal biopsies will<br /><br>be collected. The 5-ASA and N-Ac-5-ASA concentration will be determined using<br /><br>quantitative HPLC analysis.<br /><br>The main study parameters/endpoints include: 5-ASA concentration in faeces,<br /><br>expressed in mgs in patients with active and quiescent disease.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- faecal excretion of 5-ASA in 24-hours faeces expressed in % of ingested dose<br /><br>- faecal excretion of 5-ASA in 24-hours faeces expressed correlation to dry<br /><br>weight<br /><br>- faecal N-Ac-5-ASA concentration in 24-hours faeces expressed in % and mg and<br /><br>in relation to dry weight<br /><br>- mucosal 5-ASA and N-Ac-5-ASA concentration in colonic biopsies expressed in<br /><br>ng/mg<br /><br>- 5-ASA and N-Ac-5-ASA concentration in 24 hours urine expressed in % and mg<br /><br>- composition of gut microbiome<br /><br>All in patients with active and quiescent disease ulcerative colitis</p><br>