Not Yet RecruitingNot Applicable

PPI Refractory - GERD Mechanisms in Systemic Sclerosis

147 participantsStarted 2025-07-01

Plain-language 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.

Who can participate

Age range16 Years

SexALL

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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.

What they're measuring

Prevalence of PPI-refractory GERD

Timeframe: At the end of double PPI and health intervention period (8 - 12 weeks)

Trial details

NCT IDNCT07022912

SponsorHospital Universitari Vall d'Hebron Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-07-01

Contact for this trial

Luis G Alcala-Gonzalez, MD PhD

934893000 luisgerardo.alcala@vallhebron.cat