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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.5 years study duration

Study Start

First participant enrolled

July 1, 2014

Completed

16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed

7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed

Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

3.5 years

First QC Date

July 17, 2014

Last Update Submit

February 7, 2023

Conditions

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

Keywords

acid pocketGERDBarrett

Outcome Measures

Primary Outcomes (1)

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
participants will be followed for 24 hours

Secondary Outcomes (1)

number of reflux episodes
24 hours

Other Outcomes (1)

acid pocket contents
1 year