The Use of a Non-absorbable Marker for the Evaluation of the Gastrointestinal Transit

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Katholieke Universiteit Leuven
Sponsor:
Information provided by (Responsible Party):
Bart Hens, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01780909
First received: January 29, 2013
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.

Condition Intervention
Concentration-Time Profiles in Stomach & Intestine.
Drug: Paromomycin Sulfate Fasted State
Drug: Paromomycin Sulfate Fed State
Drug: Paromomycin Sulfate w/ domperidone
Drug: Paromomycin Sulfate w/ loperamide HCl

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
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)

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Concentration-time profiles of the drug paromomycin sulfate in the stomach and intestine [ Time Frame: This concentration-time profiles in the stomach and intestine will be measured for 4 hours. ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2013
Estimated Study Completion Date: December 2017
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paromomycin Sulfate Fasted State
Intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water, in fasted state. Fasted state means that you have eaten nothing for 12 hours for the investigation and only have been drinking 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.
Drug: Paromomycin Sulfate Fasted State
Other Name: 250mg Paromomycin Sulfate (1 tablet) will be dissolved in 240mL water and will be given to the healthy volunteer
Experimental: Paromomycin Sulfate Fed State
Intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water, in fed state. Fed state means that you have eaten nothing for 12 hours for the investigation and only have been drinking water. When you arrive at the hospital for the clinical trial, you will receive an Ensure Plus Shake, after the gastrointestinal catheters are placed. 20 minutes after the intake of the shake, you will receive the a glass of water, where Gabbroral is in dissolved. 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.
Drug: Paromomycin Sulfate Fed State
Other Name: Ensure Plus shake will be given 20 minutes before intake of paromomycin sulfate.
Experimental: Paromomycin Sulfate w/ Domperidone
Intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water, in fasted state, in addition of the intake of Motilium® (API: domperidone 10 mg). Fasted state means that you have eaten nothing for 12 hours for the investigation and only have been drinking water. 20 minutes for the intake of the medicine, you will take 2 tablets of Motilium®, which stimulates the gastric emptying. 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.
Drug: Paromomycin Sulfate w/ domperidone
Other Name: Intake of 2 tablets Motilium(API domperidone) before The intake of paromomycin sulfate.
Experimental: Paromomycin Sulfate w/ Loperamide HCl
Intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water, in fasted state, in addition of the intake of Imodium® (API: loperamide HCl 2 mg). Fasted state means that you have eaten nothing for 12 hours for the investigation and only have been drinking water. 20 minutes for the intake of the medicine, you will take 2 tablets of Imodium®, which has an inhibited effect on the intestine. 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.
Drug: Paromomycin Sulfate w/ loperamide HCl
Other Name: Intake of 2 tablets Imodium (API Loperamide HCl) before The intake of paromomycin sulfate.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01780909

Contacts
Contact: Bart Hens, Pharmacist +3216330302 bart.hens@pharm.kuleuven.be

Locations
Belgium
Gasthuisberg Recruiting
Leuven, BE, Belgium, 3000
Sub-Investigator: Jan Tack, PhD MD         
Sponsors and Collaborators
Katholieke Universiteit Leuven
  More Information

No publications provided

Responsible Party: Bart Hens, Pharmacist, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01780909     History of Changes
Other Study ID Numbers: DDD13PM
Study First Received: January 29, 2013
Last Updated: January 28, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Antidiarrheals
Domperidone
Loperamide
Paromomycin
Amebicides
Anti-Bacterial Agents
Anti-Infective Agents
Antiemetics
Antiparasitic Agents
Antiprotozoal Agents
Autonomic Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014