Drug absorption in people with an ostomy
Beeinflussung Der Resorption Von Arzneimitteln Bei Stoma Patient*Innen
This study will test whether commonly used psychotropic medicines and newer oral blood thinners reach expected levels in adults who have an ileostomy or colostomy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | WiGeV Klinik Ottakring Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT07138326 on ClinicalTrials.gov |
What this trial studies
This is an observational monitoring project at a single center in Vienna that follows adults with an ileostomy or colostomy who have had their stoma for at least seven days. Participants must have been taking one or more specified psychotropic drugs or a NOAC for at least seven days, and the team will use blood tests and, where applicable, clinical measures (for example blood pressure or blood sugar) to determine absorption. The goal is to determine whether therapeutic drug levels are achieved in ostomy patients, addressing a gap left by approval studies and limited case reports. Results will help clarify whether dosing or monitoring practices should differ for people with stomas.
Who should consider this trial
Good fit: Adults (18+) with an ileostomy or colostomy in place for at least seven days who have been taking one or more of the listed psychotropic drugs or NOACs for at least seven days are eligible.
Not a fit: People who are not taking any of the listed medications, who had their stoma placed fewer than seven days ago, or who cannot communicate due to an insurmountable language barrier are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help clinicians know when medications need different dosing or closer monitoring in ostomy patients to ensure effectiveness and safety.
How similar studies have performed: Previous evidence consists mainly of case reports and very small patient series, so systematic, larger data are limited and this approach is not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Planned inclusion criteria: * Male and female patients aged ≥18 years * Belonging to a collective * Ileostomy since ≥7d * Colostomy since ≥7d The stoma must have been inserted at least 7d ago to ensure that a steady state concentration is achieved. * Taking ≥1 of the following active substances since ≥7d: * Psychotropic drugs: citalopram, clozapine, duloxetine, escitalopram, melperone, mianserin, milnacipran, mirtazapine, olanzapine, paliperidone, paroxetine, pregabalin, prothipendyl, quetiapine, risperidone, sertraline, trazodone, venlafaxine * NOACs: edoxaban, rivaroxban, apixaban Exclusion Criteria: Insurmountable language barrier
Where this trial is running
Vienna, State of Vienna
- WiGeV Klinik Ottakring — Vienna, State of Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Irene Lagoja, Dr
- Email: irene.lagoja@gesundheitsverbund.at
- Phone: +431491505508
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.