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Relationship Between Gastric Accommodation, TLESRs and Reflux in HV and in GERD With or Without Overlapping Dyspepsia

NCT03788109 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-12-06

No results posted yet for this study

Summary

Our group recently studied the relationship between intra-gastric pressure (IGP) and reflux events after a meal, both in gastro-esophageal reflux disease (GERD) and in healthy volunteers (HV). Ingestion of a meal was accompanied by a drop in IGP, probably representing gastric accommodation (GA). However, the magnitude of this IGP drop varied, and was inversely correlated with the number of transient lower esophageal sphincter relaxations (TLESRs) and the number of reflux events, both in patients and in HV: a smaller meal-induced drop in IGP was associated with a higher rate of reflux events, and vice versa. These findings suggest that impaired GA is a trigger for reflux. Furthermore, impaired GA is a well-established mechanism underlying symptom generation in functional dyspepsia (FD). Hence, the investigators hypothesize that impaired GA is an important pathophysiological feature explaining the overlap between GERD and FD. To evaluate this hypothesis, the investigators will study the relationship between GA, TLESRs and reflux events in HV and in a group of GERD patients which will be categorized as pure GERD or GERD/FD overlap.

Conditions

  • Gastro-esophageal Reflux Disease
  • Functional Dyspepsia
  • Health

Interventions

PROCEDURE

device: combined solid state HRiM

The HRiM catheter (Medical Measurement Systems, Enschede, The Netherlands) incorporating 36 pressure sensors, spaced at 2 cm in the stomach and esophagus and at 1 cm in the LES and upper esophageal sphincter (UES), and 16 impedance channels throughout the esophagus, will be placed transnasally, after topical anesthesia. Manometry will be used to record pressures in the stomach, the esophagus, the LES and the UES. In this way, it is possible to detect and characterize TLESRs, and to measure GA. The impedance channels will be used to measure bolus movement, and thus to detect and characterize gastro-esophageal reflux.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Jan Tack, Prof. Dr. · KULEUVEN, UZLEUVEN

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2018-06-15
Completion
2018-06-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03788109 on ClinicalTrials.gov