Status:
UNKNOWN
Effect of MIST on Esophageal Sensitivity in Patients With rGERD
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Stress
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Effect of acute psychosocial stress on esophageal sensitivity in patients with refractory gastro-esophageal reflux disease and healthy volunteers.
Detailed Description
Gastro-esophageal reflux disease (GERD), defined as the presence of symptoms or lesions that can be attributed to the reflux of gastric contents into the esophagus, is an increasingly prevalent condit...
Eligibility Criteria
Inclusion
- 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
- 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 that affect sensitivity: anti-depressants (selective serotonin re-uptake inhibitors and tricyclic antidepressants; SSRIs and TCA and daily use of benzodiazepines);
- Pregnancy or breastfeeding;
- History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 22 2024
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05429034
Start Date
June 1 2022
End Date
June 22 2024
Last Update
June 23 2022
Active Locations (1)
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1
TARGID
Leuven, Vlaams-Brabant, Belgium