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PPI Refractory - GERD Mechanisms in Systemic Sclerosis

NCT07022912 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 147

Last updated 2025-06-15

No results posted yet for this study

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.

Conditions

  • Systemic Sclerosis (SSc)
  • GERD (Gastroesophageal Reflux Disease)

Interventions

OTHER

educational healthcare intervention

This intervention will be applyed at the beginning of the study

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Evaluation of GERD severity

Objective evaluation of GERD severity on PPI therapy will be performed.

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2027-07-01
Completion
2027-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07022912 on ClinicalTrials.gov