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Acid Pocket: Position and Aspiration

C

Catholic University (KU) of Leuven

Status

Completed

Conditions

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

Treatments

Device: multi-pH-impedance manometry catheter

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 5 patient groups

healthy volunteers
Other group
Description:
healthy volunteers (no gastric complains)
Treatment:
Device: multi-pH-impedance manometry catheter
PPI responders
Other group
Description:
proven reflux, good symptom relief upon PPI therapy
Treatment:
Device: multi-pH-impedance manometry catheter
PPI non-responders
Other group
Description:
proven reflux disease, poor symptom control (less then 50% symptom reduction) upon PPI therapy (2x40mg omeprazole)
Treatment:
Device: multi-pH-impedance manometry catheter
Barrett - no dysplasia
Other group
Description:
proven barrett with no dysplasia on biopsies
Treatment:
Device: multi-pH-impedance manometry catheter
barrett - high grade dysplasia
Other group
Description:
proven barrett with high grade dysplasia on biopsies
Treatment:
Device: multi-pH-impedance manometry catheter

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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