Acid Pocket: Position and Aspiration

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199002
• Other study ID #: S55731
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2023
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• multi-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.

Locations

Country	Name	City	State
Belgium	Catholic University Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	acid pocket contents	after collection of all acid pocket, pockets will be processed to determine it's exact chemical content.	1 year
Primary	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	number of reflux episodes	number of reflux episodes will be counted and compared between the different groups.	24 hours