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Trial record 18 of 41 for:    Recruiting, Not yet recruiting, Available Studies | Dyspepsia

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

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ClinicalTrials.gov Identifier: NCT03788109
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven

Brief 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.

Condition or disease Intervention/treatment Phase
Gastro-esophageal Reflux Disease Functional Dyspepsia Health Procedure: device: combined solid state HRiM Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Relationship Between Gastric Accommodation, Transient Lower Esophageal Sphincter Relaxations and Reflux Events in Healthy Subjects and in Gastro-esophageal Reflux Disease Patients With or Without Overlapping Dyspepsia
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Indigestion

Arm Intervention/treatment
device: combined solid state HRiM
combined solid state high resolution esophageal impedance and manometry (HRiM)
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.




Primary Outcome Measures :
  1. Change in number transient lower esophageal sphincter relaxations [ Time Frame: 6-hour study period ]
    Change in number TLESRs between preprandial and postprandial period


Secondary Outcome Measures :
  1. Change in number of reflux episodes [ Time Frame: 6 hour study period ]
    Change in number of reflux episodes between preprandial and postprandial period

  2. Change in intragastric pressure [ Time Frame: 6 hour study period ]
    Change in intragastric pressure between preprandial and postprandial period



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • GERD patients:

    • typical symptoms of reflux, such as heartburn and/or regurgitation;
    • gastro-esophageal reflux assessed by 24-h pH-impedance monitoring or a positive symptom association or;
    • esophagitis assessed by upper GI endoscopy with careful evaluation of the presence and extent of a hiatal hernia (HH).
  • GERD/FD overlap:

    • FD symptoms according to the Rome III criteria. The symptoms of FD include one or more of: bothersome postprandial fullness occurring after normal sized meals, early satiation that prevents finishing a regular meal, epigastric pain, and epigastric burning at least several times per week during the last 6 months.

Exclusion Criteria:

  • Healthy volunteers:

    • history of any upper gastrointestinal (GI) symptoms or GI surgery;
    • psychological disorders;
    • any drug history;
    • use of medication altering GI motility;
    • pregnant or nursing women.
  • GERD patients:

    • psychological disorders;
    • any drug history;
    • use of medication affecting GI motility;
    • pregnant or nursing women;
    • history of GI surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788109


Contacts
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Contact: Hannelore Geysen, MSc +32 16 32 49 21 hannelore.geysen@kuleuven.be
Contact: Ans Pauwels, MPharm, PhD +32 16 37 75 59 ans.pauwels@med.kuleuven.be

Locations
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Belgium
Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven Campus Gasthuisberg O&N1 Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Jan Tack, Prof. Dr.    +32 16 37 74 74    jan.tack@med.kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Jan Tack, Prof. Dr. KULEUVEN, UZLEUVEN

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Responsible Party: Prof Dr Jan Tack, Prof. Dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03788109     History of Changes
Other Study ID Numbers: S57615
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyspepsia
Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases