Short Bowel Syndrome
Conditions
Interventions
We designed a single-centre explorative in vivo study of enteral antibiotic absorption in patients with short bowel syndrome.
1. We will include a total of 16 patients and patients will be allocated
Sponsors
Radboudumc
Eligibility
Inclusion criteria
Inclusion criteria: - Patients with current use of long-term home parenteral nutrition (> 3 consecutive months) and clinically stable - Diagnosed with SBS (total small bowel length 200cm or less after Treitz ligamentum) - Age 18 years of older - Signed Informed Consent - Patient is fully able to understand the nature of the proposed intervention.
Exclusion criteria
Exclusion criteria: - Active vomiting, worsening or new diarrhea - Contra-indications (for example allergies or interfering co-medication) for any of the study treatments - Impaired renal function (creatinin clearance 35) - Any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the enteral absorption of orally administered ciprofloxacin, clindamycin, flucloxacillin and fluconazole, defined as the blood plasma concentration (µg/ml). The total concentration will be measured. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean plasma concentration-time profile of all study drugs after oral administration (Emami et al. 2016); influence of patient characteristics on enteral drug absorption, any complication, allergies or adverse events during intervention. | — |
Contacts
Public ContactMichelle Gompelman
Radboudumc
Outcome results
None listed