Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT05429034
Eligibility Criteria:
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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05429034
Study Brief:
Protocol Section:
NCT05429034