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Acid Pocket: Position and Aspiration

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ClinicalTrials.gov Identifier: NCT02199002
Recruitment Status : Recruiting
First Posted : July 24, 2014
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
Guy Boeckxstaens, KU Leuven

Brief 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. 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.


Condition or disease Intervention/treatment Phase
GERD - PPI Responders GERD - PPI Non-responders Barrett Esophagus Healthy Volunteers Device: multi-pH-impedance manometry catheter Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Acid Pocket: Different Position and Chemical Content Between Healthy Volunteers and GERD Patients
Study Start Date : July 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
healthy volunteers
healthy volunteers (no gastric complains)
Device: multi-pH-impedance manometry catheter
a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.

PPI responders
proven reflux, good symptom relief upon PPI therapy
Device: multi-pH-impedance manometry catheter
a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.

PPI non-responders
proven reflux disease, poor symptom control (less then 50% symptom reduction) upon PPI therapy (2x40mg omeprazole)
Device: multi-pH-impedance manometry catheter
a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.

Barrett - no dysplasia
proven barrett with no dysplasia on biopsies
Device: multi-pH-impedance manometry catheter
a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.

barrett - high grade dysplasia
proven barrett with high grade dysplasia on biopsies
Device: multi-pH-impedance manometry catheter
a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. number of reflux episodes [ Time Frame: 24 hours ]
    number of reflux episodes will be counted and compared between the different groups.


Other Outcome Measures:
  1. acid pocket contents [ Time Frame: 1 year ]
    after collection of all acid pocket, pockets will be processed to determine it's exact chemical content.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • signed informed consent
  • older than 18 years
  • fit to criteria of 'study population' (HV, PPI responder, PPI non-responder, Barrett)

Exclusion Criteria:

  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199002


Contacts
Contact: An Moonen, MD an.moonen@med.kuleuven.be

Locations
Belgium
Catholic University Leuven Recruiting
Leuven, Belgium, 3000
Contact: An Moonen, MD       an.moonen@med.kuleuven.be   
Sponsors and Collaborators
KU Leuven
Investigators
Principal Investigator: Guy Boeckxstaens, MD, PhD Catholic University Leuven

Responsible Party: Guy Boeckxstaens, MD, PhD, KU Leuven
ClinicalTrials.gov Identifier: NCT02199002     History of Changes
Other Study ID Numbers: S55731
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by Guy Boeckxstaens, KU Leuven:
acid pocket
GERD
Barrett

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases