An explorative study determining the oral antibiotic drug absorption in patients with short bowel syndrome.
- Conditions
- Short Bowel Syndrome
- Registration Number
- NL-OMON27546
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 16
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.
-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 <30ml/min/1,73m2)
-Pregnancy
-Morbid obesity (BMI >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.<br>