The Use of a Non-absorbable Marker for the Evaluation of the Gastrointestinal Transit
Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
Aim of the study The aim of this study is to use Gabbroral® oral tablet formulation as marker
for the evaluation of the gastrointestinal transit. By collecting and analyzing both gastric
and intestinal fluids on different time points, the transfer dissolution can be distracted.
For this study stomach fluid and intestinal fluid will be collected after oral intake of a
commercially available dosing form of Paromomycin Sulfate (Gabbroral® oral tablet
formulation), which is dissolved in a glas of 240mL water, in fasted or fed state. Four
intake conditions will be tested on four different test days (with an intermediate period of
at least 7 days).
1. intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL
water, in fasted state.
2. intake of Gabbroral® oral tablet formulation in fed state.
3. Intake of 2 tablets of Motilium® (API: domperidone 10 mg) 20 minutes before the intake
of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water.
4. Intake of 2 tablets of Motilium® (API: loperamide HCl 2 mg) 20 minutes before the intake
of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water.
Conduct of the study
- The study consists of four testing days in the University Hospitals Leuven, Gasthuisberg
campus.
- On each test day you come at the agreed time in fasting State to the Gastroenterology
Department at UZ Leuven (Gasthuisberg, floor 0, Orange arrow). Fasted state means that
you have eaten nothing for 12 hours for the investigation and only have been drinking
water.
- A basic clinical anamnesis will be taken by a doctor to make sure that you are a healthy
volunteer for our study. For making sure that you are HIV negative, you will undergo an
HIV test. In case of a female volunteer, a pregnancy test will be taken in account to
make sure you are not pregnant.
- Upon arrival at the hospital through the nose or the mouth two probes: one in the
stomach and one in the gut. The position of both probes is controlled using fluoroscopy
(x-ray).
- After a stabilisation period of ca. 20 min you will be asked for taking a single dose of
Gabbroral® oral tablet formulation. On four different test days, with an intermediate
period of at least 7 days, we will follow every one of following intake conditions:
1. intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of
240mL water, in fasted state.
2. intake of Gabbroral® oral tablet formulation in fed state.
3. Intake of 2 tablets of Motilium® (API: domperidone 10 mg) 20 minutes before the
intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of
240mL water.
4. Intake of 2 tablets of Motilium® (API: loperamide HCl 2 mg) 20 minutes before the
intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of
240mL water.
- After intake of the medicine at regular intervals, gastrointestinal fluids will be
aspirated over 4 hours. You sit in a comfortable position in bed; eating and sleeping is
not permitted (after 2 hours you have the possibility to drink some water).
- After 4 hours, the gastrointestinal catheters will be removed and you may eat and roam
freely.