Fact CheckerSign in

NCT07022912Not yet recruiting

PPI Refractory - GERD Mechanisms in Systemic Sclerosis

Objective Assessment of Gastrointestinal Involvement in Patients With Systemic Sclerosis and Gastroesophageal Reflux Symptoms Refractory to Proton Pump Inhibitors.

Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
147 (estimated)
First submitted
6 Jun 2025
Start date
1 Jul 2025
Primary completion date
1 Jul 2027
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
NCT number
NCT07022912

What you commit to

  • Study type: Observational
  • Planned participants: 147
  • From 1 Jul 2025 to the primary completion date, 1 Jul 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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

Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.