ABSORB-2:An exploratie study determining the oral antibiotic drug absorption in patients with short bowel syndrome.

Completed

• Conditions: short bowel syndrome; surgical bowel resection; 10017977; 10004018

• Registration Number: NL-OMON48315
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-01-07
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

- Patients with current use of long-term home parenteral nutrition (at least 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

- 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
<p>Main study parameters/endpoints: The primary endpoint of the study is the<br /><br>enteral absorption of flucloxacillin, clindamycin, ciprofloxacin and<br /><br>fluconazole, defined as the relative oral bioavailability (in percentage) of<br /><br>the administered dose in blood plasma concentration. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p> Secondary study parameters are:<br /><br>* Comparison results of IV and PO dose and with results of the *normal<br /><br>population*<br /><br>* Cmax and time to reach Cmax (Tmax) derived from a plasma concentration curve,<br /><br>consisting of at least 4 measurements in blood plasma (T=0,1,2,4,8).<br /><br>* Blood biochemical analysis<br /><br>* Demographic information, medical history, concomitant medication<br /><br>* Complications or adverse events</p><br>