Effect of MIST on Esophageal Sensitivity in Patients With rGERD (NCT05429034) | Clinical Trial Compass
UnknownNot Applicable
Effect of MIST on Esophageal Sensitivity in Patients With rGERD
Belgium54 participantsStarted 2022-06
Plain-language summary
Effect of acute psychosocial stress on esophageal sensitivity in patients with refractory gastro-esophageal reflux disease and healthy volunteers.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged between 18 to 65 years;
* Patients need to be classified as having gastroesophageal reflux disease and can be divided in three different groups (based on the Lyon consensus):
* True GERD: Acid exposure time (AET) \>6% off PPI or \>80 reflux episodes on PPI
* RHS: AET \<4% off PPI or \<40 reflux episodes on PPI and positive symptom association
* FH: AET \<4% off PPI or \<40 reflux episodes on PPI and negative symptom association --\> Result based on a measurement maximum 1 year ago.
* Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.
* Being able to stop PPI intake for 10 - 14 days before the study visit.
Exclusion Criteria:
* Endoscopic signs of severe erosive esophagitis (grade C or D, Los Angeles classification) on endoscopy performed off PPI treatment in the 12 months prior to screening, or ≥ grade B when endoscopy is performed on PPI treatment;
* Systemic diseases, known to affect esophageal motility (i.e. systemic sclerosis);
* Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed);
* Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator;
* Severe anxiety/depressive disorder (assessed with the GAD7, PHQ9 and PHQ15);
* Medication intake tha…
What they're measuring
1
Esophageal mechanical sensitivity
Timeframe: Assessed during visit 1 at time point 75 minutes
2
Esophageal chemical sensitivity
Timeframe: Assessed during visit 1 at time point 180 minutes