Concentration-Time Profiles in Stomach & Intestine.NCT01780909
The Use of a Non-absorbable Marker for the Evaluation of the Gastrointestinal Transit
A study testing Paromomycin Sulfate Fasted State, Paromomycin Sulfate Fed State and Paromomycin Sulfate w/ domperidone in people with Concentration-Time Profiles in Stomach & Intestine., run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Concentration-Time Profiles in Stomach & Intestine.
- What is being tested?
- Paromomycin Sulfate Fasted State, Paromomycin Sulfate Fed State and Paromomycin Sulfate w/ domperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- age: 20-35 year
Who cannot join
- Diseases
- Acute/chronic gastrointestinal disorders
- Medication use
- Possible pregnancy
- Frequent exposure to x-ray radiation during the past year
- HIV positive
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Gasthuisberg
Leuven, BE, 3000
Jan Tack, PhD MD
About this study
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)
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).
- intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water, in fasted state.
- intake of Gabbroral® oral tablet formulation in fed state.
- 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.
- 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.
Read more
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:
- intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water, in fasted state.
- intake of Gabbroral® oral tablet formulation in fed state.
- 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.
- 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.
- Being tested
- Paromomycin Sulfate Fasted State, Paromomycin Sulfate Fed State, Paromomycin Sulfate w/ domperidone, Paromomycin Sulfate w/ loperamide HCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paromomycin Sulfate Fasted StateDrug
Also called 250mg Paromomycin Sulfate (1 tablet) will be dissolved in 240mL water and will be given to the healthy volunteer
Paromomycin Sulfate Fed StateDrug
Also called Ensure Plus shake will be given 20 minutes before intake of paromomycin sulfate.
Paromomycin Sulfate w/ domperidoneDrug
Also called Intake of 2 tablets Motilium(API domperidone) before The intake of paromomycin sulfate.
Paromomycin Sulfate w/ loperamide HClDrug
Also called Intake of 2 tablets Imodium (API Loperamide HCl) before The intake of paromomycin sulfate.
| Study group | Role | What they receive |
|---|---|---|
| Paromomycin Sulfate Fasted State | Experimental | 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. Receives: Drug: Paromomycin Sulfate Fasted State |
| Paromomycin Sulfate Fed State | Experimental | 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. Receives: Drug: Paromomycin Sulfate Fed State |
| Paromomycin Sulfate w/ Domperidone | Experimental | 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. Receives: Drug: Paromomycin Sulfate w/ domperidone |
| Paromomycin Sulfate w/ Loperamide HCl | Experimental | 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. Receives: Drug: Paromomycin Sulfate w/ loperamide HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration-time profiles of the drug paromomycin sulfate in the stomach and intestine
Measured: This concentration-time profiles in the stomach and intestine will be measured for 4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concentration-Time Profiles in Stomach & Intestine.Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bart Hens, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780909
- Sponsor's protocol ID
- DDD13PM
- Status last verified
- Jan 2014
- First submitted
- 29 Jan 2013
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01780909
- Acronym / sponsor ID
- DDD13PM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water, in fasted state.
- intake of Gabbroral® oral tablet formulation in fed state.
- 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.
- 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:
- intake of Gabbroral® oral tablet formulation, which will be dissolved in a glas of 240mL water, in fasted state.
- intake of Gabbroral® oral tablet formulation in fed state.
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Paromomycin Sulfate Fasted State | Experimental | Drug: Paromomycin Sulfate Fasted StateIntake 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. |
| Paromomycin Sulfate Fed State | Experimental | Drug: Paromomycin Sulfate Fed StateIntake 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. |
| Paromomycin Sulfate w/ Domperidone | Experimental | Drug: Paromomycin Sulfate w/ domperidoneIntake 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. |
| Paromomycin Sulfate w/ Loperamide HCl | Experimental | Drug: Paromomycin Sulfate w/ loperamide HClIntake 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- age: 20-35 year
Key exclusion criteria (6 listed)
- Diseases
- Acute/chronic gastrointestinal disorders
- Medication use
- Possible pregnancy
- Frequent exposure to x-ray radiation during the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paromomycin Sulfate Fasted StateAlso: 250mg Paromomycin Sulfate (1 tablet) will be dissolved in 240mL water and will be given to the healthy volunteer | Drug | Paromomycin Sulfate Fasted State |
| Paromomycin Sulfate Fed StateAlso: Ensure Plus shake will be given 20 minutes before intake of paromomycin sulfate. | Drug | Paromomycin Sulfate Fed State |
| Paromomycin Sulfate w/ domperidoneAlso: Intake of 2 tablets Motilium(API domperidone) before The intake of paromomycin sulfate. | Drug | Paromomycin Sulfate w/ Domperidone |
| Paromomycin Sulfate w/ loperamide HClAlso: Intake of 2 tablets Imodium (API Loperamide HCl) before The intake of paromomycin sulfate. | Drug | Paromomycin Sulfate w/ Loperamide HCl |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paromomycin Sulfate Fasted State, Paromomycin Sulfate Fed State and Paromomycin Sulfate w/ domperidone in people with Concentration-Time Profiles in Stomach & Intestine., run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bart Hens, Pharmacist (+3216330302, bart.hens@pharm.kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014; AzTrials last refreshed its copy on 26 Oct 2026.