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NCT Number: NCT02199002

Acid Pocket: Position and Aspiration

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.

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Key information

Conditions

GERD - PPI Responders Barrett Esophagus Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders GERD - PPI Non-responders Gastroesophageal Reflux Gastrointestinal Diseases Healthy Volunteers Neoplasms Precancerous Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multi-pH-impedance manometry catheter

Device

a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.

Primary outcomes

  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 outcomes

  1. number of reflux episodes

    Time frame: 24 hours

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

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 24, 2014
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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