GERD - PPI RespondersNCT02199002
Acid Pocket: Position and Aspiration
A study testing multi-pH-impedance manometry catheter in people with GERD - PPI Responders and GERD - PPI Non-responders, run by KU Leuven at 1 site in Belgium.
Trial summary
Gastroesophageal reflux disease (GERD) is a very common condition affecting up to 30% of adults. To date, therapy consists of powerful acid suppression with proton pump inhibitors (PPI). Nevertheless, only 60-70% of GERD patients report complete symptom relief with this therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- GERD - PPI Responders, GERD - PPI Non-responders, Barrett Esophagus
- What is being tested?
- multi-pH-impedance manometry catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2014to 31 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- signed informed consent
- older than 18 years
- fit to criteria of 'study population' (HV, PPI responder, PPI non-responder, Barrett)
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acid Pocket: Different Position and Chemical Content Between Healthy Volunteers and GERD Patients
Gastroesophageal reflux disease (GERD) is a very common condition affecting up to 30% of adults. To date, therapy consists of powerful acid suppression with proton pump inhibitors (PPI). Nevertheless, only 60-70% of GERD patients report complete symptom relief with this therapy. As the mechanisms underlying symptom perception in PPI resistant patients are not fully understood, there is currently no adequate therapy available.
It is becoming increasingly clear that reflux, especially in the postprandial period, occurs from a reservoir of acid floating on top of the meal: the so-called "acid pocket". In this study, we aim to investigate further the acid pocket by determining its exact position and chemical contents between healthy volunteers, GERD patient who respond well and bad to PPI therapy and GERD patients with barrett's esophagus.
Read the detailed description
A costume made multi-pH-impedance manometry catheter will be placed in the esophagus and clipped to the Z-line. Patients then will be given a standardized meal and the position of the acid pocket will be measured. After two hours the pocket will be aspirated through a gastric catheter. Then, patients will be allowed to return home and the study will be continued for another 22 hours.
The special catheter will be removed at the end of the study. Collected acid pockets will be used to analyze content and perform permeability experiments.
Data of the 24-hour experiment will be used to evaluate the position of the acid pocket and number of reflux episodes.
- Being tested
- multi-pH-impedance manometry catheter
- Keywords
- acid pocket, GERD, Barrett
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-pH-impedance manometry catheterDevice
a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Other | healthy volunteers (no gastric complains) Receives: Device: multi-pH-impedance manometry catheter |
| PPI responders | Other | proven reflux, good symptom relief upon PPI therapy Receives: Device: multi-pH-impedance manometry catheter |
| PPI non-responders | Other | proven reflux disease, poor symptom control (less then 50% symptom reduction) upon PPI therapy (2x40mg omeprazole) Receives: Device: multi-pH-impedance manometry catheter |
| Barrett - no dysplasia | Other | proven barrett with no dysplasia on biopsies Receives: Device: multi-pH-impedance manometry catheter |
| barrett - high grade dysplasia | Other | proven barrett with high grade dysplasia on biopsies Receives: Device: multi-pH-impedance manometry catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
acid pocket position
Acid position will be determined relatively to the lower esophageal sfincter. Differences in position between healthy volunteers, PPI responders, PPI non-responders and patients with barrett esophagus will be evaluated
Measured: participants will be followed for 24 hours
Secondary outcomes (1)
number of reflux episodes
number of reflux episodes will be counted and compared between the different groups.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startJul 2014
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERD - PPI RespondersStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Boeckxstaens, KU Leuven
- Investigators
- Guy Boeckxstaens, MD, PhD, Principal investigator, Catholic University Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199002
- Sponsor's protocol ID
- S55731
- Status last verified
- Feb 2023
- First submitted
- 17 Jul 2014
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acid Pocket: Different Position and Chemical Content Between Healthy Volunteers and GERD Patients
- ClinicalTrials.gov ID
- NCT02199002
- Acronym / sponsor ID
- S55731
- Keywords
- acid pocket, GERD, Barrett
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 24 Jul 2014 (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.
Gastroesophageal reflux disease (GERD) is a very common condition affecting up to 30% of adults. To date, therapy consists of powerful acid suppression with proton pump inhibitors (PPI). Nevertheless, only 60-70% of GERD patients report complete symptom relief with this therapy. As the mechanisms underlying symptom perception in PPI resistant patients are not fully understood, there is currently no adequate therapy available.
It is becoming increasingly clear that reflux, especially in the postprandial period, occurs from a reservoir of acid floating on top of the meal: the so-called "acid pocket". In this study, we aim to investigate further the acid pocket by determining its exact position and chemical contents between healthy volunteers, GERD patient who respond well and bad to PPI therapy and GERD patients with barrett's esophagus.
Detailed description
A costume made multi-pH-impedance manometry catheter will be placed in the esophagus and clipped to the Z-line. Patients then will be given a standardized meal and the position of the acid pocket will be measured. After two hours the pocket will be aspirated through a gastric catheter. Then, patients will be allowed to return home and the study will be continued for another 22 hours.
The special catheter will be removed at the end of the study. Collected acid pockets will be used to analyze content and perform permeability experiments.
Data of the 24-hour experiment will be used to evaluate the position of the acid pocket and number of reflux episodes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Other | Device: multi-pH-impedance manometry catheterhealthy volunteers (no gastric complains) |
| PPI responders | Other | Device: multi-pH-impedance manometry catheterproven reflux, good symptom relief upon PPI therapy |
| PPI non-responders | Other | Device: multi-pH-impedance manometry catheterproven reflux disease, poor symptom control (less then 50% symptom reduction) upon PPI therapy (2x40mg omeprazole) |
| Barrett - no dysplasia | Other | Device: multi-pH-impedance manometry catheterproven barrett with no dysplasia on biopsies |
| barrett - high grade dysplasia | Other | Device: multi-pH-impedance manometry catheterproven barrett with high grade dysplasia on biopsies |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- signed informed consent
- older than 18 years
- fit to criteria of 'study population' (HV, PPI responder, PPI non-responder, Barrett)
Key exclusion criteria (1 listed)
- pregnancy
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 |
|---|---|---|
| multi-pH-impedance manometry cathetera special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed. | Device | Barrett - no dysplasia, PPI non-responders, PPI responders, barrett - high grade dysplasia, healthy volunteers |
Primary outcome
acid pocket position
Time frame: participants will be followed for 24 hours
Acid position will be determined relatively to the lower esophageal sfincter. Differences in position between healthy volunteers, PPI responders, PPI non-responders and patients with barrett esophagus will be evaluated
1 secondary outcome
number of reflux episodes
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
Related trials for GERD - PPI Responders
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GERD - PPI Non-responders
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.
Guy Boeckxstaens, MD, PhD principal investigator
Catholic University Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-pH-impedance manometry catheter in people with GERD - PPI Responders and GERD - PPI Non-responders, 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 10 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acid pocket position (time frame: participants will be followed for 24 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 10 Feb 2023.