Research for bowel absorption of antibiotic tablets in patients with short bowel syndrome

Phase 1

• Conditions: short bowel syndrome, home parenteral nutrition; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-002587-28-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-22
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

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 clinical trial of medicinal product
• Study Design: Not specified