PPI Refractory - GERD Mechanisms in Systemic Sclerosis

Launched by HOSPITAL UNIVERSITARI VALL D'HEBRON RESEARCH INSTITUTE · Jun 6, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding why some patients with systemic sclerosis (SSc) continue to experience gastroesophageal reflux disease (GERD) symptoms, like heartburn and regurgitation, even after taking medication called proton pump inhibitors (PPIs) that are supposed to help. The researchers want to discover the underlying reasons for these ongoing symptoms. To do this, they will conduct tests to measure how well the esophagus (the tube that connects your mouth to your stomach) is working and to analyze the reflux patterns in patients who still feel discomfort.

To participate in this study, you must have a confirmed diagnosis of systemic sclerosis and have been experiencing reflux symptoms at least three times a week for the past three months, even while on PPIs. However, there are some exclusions; for instance, if you've had certain types of surgeries on your digestive tract or have severe heart or lung issues, you may not qualify. If you join the study, you can expect to undergo standard diagnostic tests that will help researchers collect important data to better understand the connection between SSc and GERD. This research is significant as it aims to improve treatment options for patients who are struggling with these symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Previous surgery altering the anatomy or motility of the upper digestive tract, including fundoplication, esophageal myotomy, gastrectomy, or bariatric surgery.
• • Severe pulmonary or cardiac disease requiring intravenous vasodilators, continuous oxygen therapy, or ventricular assist devices, preventing the performance of gastrointestinal motility tests.
• • Pregnancy at the time of evaluation or planned pregnancy during the duration of the study.
• • Neuromuscular disorders other than systemic sclerosis that may affect gastrointestinal motility.
• • Prior diagnosis of functional gastrointestinal disorders, such as irritable bowel syndrome or functional dyspepsia, that may interfere with the interpretation of results.