PPI Refractory - GERD Mechanisms in Systemic Sclerosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16+
SponsorHospital Universitari Vall d'Hebron Research Institute
About this trial
The goal of this observational study is to learn about the mechanisms of gastroesophageal reflux disease (GERD) in patients with systemic sclerosis (SSc) who continue to experience reflux symptoms despite treatment with proton pump inhibitors (PPIs). The main question it aims to answer is:
What are the underlying gastrointestinal mechanisms contributing to PPI-refractory reflux symptoms in patients with SSc?
Participants with a confirmed diagnosis of SSc and persistent reflux symptoms despite PPI therapy will undergo standard-of-care diagnostic tests, including high-resolution esophageal manometry and pH-impedance monitoring. Clinical data and test results will be collected and analyzed to identify patterns of motility dysfunction and reflux characteristics associated with refractory symptoms.
Eligibility criteria
Qualifiers
Systemic sclerosis by ACR/EULAR 2023 criteria AND/OR Leroy Medsger classification criteria
Reflux symptoms (Heartburn AND/OR Regurgitation), at least 3 times a week over the last 3 months despite PPI therapy
Disqualifiers
Previous surgery altering the anatomy or motility of the upper digestive tract, including fundoplication, esophageal myotomy, gastrectomy, or bariatric surgery.
Trial design
Treatments tested in this trial
- educational healthcare intervention
- Objective assessment of GI motility
- Evaluation of GERD severity
Treatment groups
147 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov