Determination of gastric acid distribution after the meal and aspiration of gastric acid

Acid pocket: Determination of position and aspiration

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001169-21-BE

Enrollment

Registered

2015-03-17

Start date

2015-04-14

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

Gastro-oesophageal reflux disease Healthy volunteers and patients with reflux disease who respond to PPI therapy and who partially respond to PPI therapy will be studied It is known, that after the meal, a pool of gastric acid forms that floats on top of the meal. This 'acid pocket' is the pool of acid from which reflux arises. In the study, the position and composition of the acid pocket will be studied in different patient groups.

Interventions

Trade Name: Pantomed Product Name: pantomed Product Code: A02BC02 Pharmaceutical Form: Tablet INN or Proposed INN: PANTOPRAZOLE SODIUM CAS Number: 138786-67-1 Concentration unit: mg milligram(s) Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - between 18 and 75 years of age - informed consent - healthy volunteer (no GI complaints) - patient with GERD (defined as oesophagitis on gastroscopy or positive pH-metry) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - pregnancy - previous gastro-oesophageal surgery - oesophageal motility diseases (e.g. achalasia)

Design outcomes

Primary

Measure	Time frame
Main Objective: To unravel underlying mechanisms of symptom perception in gastrooesophageal reflux disease. We will evaluate the differences in acid pocket position and composition in healthy volunteers (on and off PPI therapy), patients with gastrooesophageal reflux disease who respond to PPI therapy and patient who have a partial respons to PPI therapy;Secondary Objective: not applicable;Primary end point(s): number of acid pockets detected postprandially differences in position of the acid pocket compared to the lower oesophageal sfincter;Timepoint(s) of evaluation of this end point: 24 hour study other time points not applicable	—

Measure

Time frame

Main Objective: To unravel underlying mechanisms of symptom perception in gastrooesophageal reflux disease. We will evaluate the differences in acid pocket position and composition in healthy volunteers (on and off PPI therapy), patients with gastrooesophageal reflux disease who respond to PPI therapy and patient who have a partial respons to PPI therapy;Secondary Objective: not applicable;Primary end point(s): number of acid pockets detected postprandially differences in position of the acid pocket compared to the lower oesophageal sfincter;Timepoint(s) of evaluation of this end point: 24 hour study other time points not applicable

—

Secondary

Measure	Time frame
Secondary end point(s): differences in composition of the acid pocket (e.g. in bile acid content);Timepoint(s) of evaluation of this end point: not applicable	—

Countries

Belgium

Contacts

Public ContactGuy Boeckxstaens

Catholic University Leuven

guy.boeckxstaens@med.kuleuven.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026