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PPI Refractory - GERD Mechanisms in Systemic Sclerosis
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Summary
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.
Official title: Objective Assessment of Gastrointestinal Involvement in Patients With Systemic Sclerosis and Gastroesophageal Reflux Symptoms Refractory to Proton Pump Inhibitors.
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
OBSERVATIONAL
Enrollment
147
Start Date
2025-07-01
Completion Date
2027-07-01
Last Updated
2025-06-15
Healthy Volunteers
No
Interventions
educational healthcare intervention
This intervention will be applyed at the beginning of the study
Objective assessment of GI motility
Objetive assessment of gastrointestinal dysmotility in GI organs (esophagus, stomach, small bowel) will be performed using state of the art tests.
Evaluation of GERD severity
Objective evaluation of GERD severity on PPI therapy will be performed.