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Acid Pocket: Position and Aspiration

Acid Pocket: Different Position and Chemical Content Between Healthy Volunteers and GERD Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02199002
Enrollment
70
Registered
2014-07-24
Start date
2014-07-31
Completion date
2017-12-31
Last updated
2023-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

acid pocket, GERD, Barrett

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.

Interventions

DEVICEmulti-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.

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
acid pocket positionparticipants will be followed for 24 hoursAcid 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

MeasureTime frameDescription
number of reflux episodes24 hoursnumber of reflux episodes will be counted and compared between the different groups.

Other

MeasureTime frameDescription
acid pocket contents1 yearafter collection of all acid pocket, pockets will be processed to determine it's exact chemical content.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026