Clinical trial NCT01780909: The Use of a Non-absorbable Marker for the Evaluation of the Gastrointestinal Transit
Official title: The Use of a Non-absorbable Marker for the Evaluation of the Gastrointestinal Transit. Evaluatie Van de Gastrointestinale Transit Aan de Hand Van de Niet-absorbeerbare Merker Paromomycine Sulfaat (Dutch Translation)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Concentration-Time Profiles in Stomach & Intestine.
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* age: 20-35 year

Exclusion Criteria:

* Diseases
* Acute/chronic gastrointestinal disorders
* Medication use
* Possible pregnancy
* Frequent exposure to x-ray radiation during the past year
* HIV positive

Primary outcomes:
measure: Concentration-time profiles of the drug paromomycin sulfate in the stomach and intestine
timeFrame: This concentration-time profiles in the stomach and intestine will be measured for 4 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Gasthuisberg
state: BE
Study officials:
References: