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Acid Pocket: Position and Aspiration

Primary Purpose

GERD - PPI Responders, GERD - PPI Non-responders, Barrett Esophagus

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
multi-pH-impedance manometry catheter
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for GERD - PPI Responders focused on measuring acid pocket, GERD, Barrett

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Catholic University Leuven

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

healthy volunteers

PPI responders

PPI non-responders

Barrett - no dysplasia

barrett - high grade dysplasia

Arm Description

healthy volunteers (no gastric complains)

proven reflux, good symptom relief upon PPI therapy

proven reflux disease, poor symptom control (less then 50% symptom reduction) upon PPI therapy (2x40mg omeprazole)

proven barrett with no dysplasia on biopsies

proven barrett with high grade dysplasia on biopsies

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

number of reflux episodes
number of reflux episodes will be counted and compared between the different groups.

Full Information

First Posted
July 17, 2014
Last Updated
February 7, 2023
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02199002
Brief Title
Acid Pocket: Position and Aspiration
Official Title
Acid Pocket: Different Position and Chemical Content Between Healthy Volunteers and GERD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD - PPI Responders, GERD - PPI Non-responders, Barrett Esophagus, Healthy Volunteers
Keywords
acid pocket, GERD, Barrett

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy volunteers
Arm Type
Other
Arm Description
healthy volunteers (no gastric complains)
Arm Title
PPI responders
Arm Type
Other
Arm Description
proven reflux, good symptom relief upon PPI therapy
Arm Title
PPI non-responders
Arm Type
Other
Arm Description
proven reflux disease, poor symptom control (less then 50% symptom reduction) upon PPI therapy (2x40mg omeprazole)
Arm Title
Barrett - no dysplasia
Arm Type
Other
Arm Description
proven barrett with no dysplasia on biopsies
Arm Title
barrett - high grade dysplasia
Arm Type
Other
Arm Description
proven barrett with high grade dysplasia on biopsies
Intervention Type
Device
Intervention Name(s)
multi-pH-impedance manometry catheter
Intervention Description
a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.
Primary Outcome Measure Information:
Title
acid pocket position
Description
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
Time Frame
participants will be followed for 24 hours
Secondary Outcome Measure Information:
Title
number of reflux episodes
Description
number of reflux episodes will be counted and compared between the different groups.
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
acid pocket contents
Description
after collection of all acid pocket, pockets will be processed to determine it's exact chemical content.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Boeckxstaens, MD, PhD
Organizational Affiliation
Catholic University Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

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Acid Pocket: Position and Aspiration

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