PPI Refractory - GERD Mechanisms in Systemic Sclerosis

ConditionsSystemic Sclerosis (SSc)GERD (Gastroesophageal Reflux Disease)

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age16+

SponsorHospital Universitari Vall d'Hebron Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previous surgery altering the anatomy or motility of the upper digestive tract, including fundoplication, esophageal myotomy, gastrectomy, or bariatric surgery.

Trial population

Patients with systemic sclerosis and PPI-refractory reflux symptoms who are members of the Spanish Association of Patients with Systemic Sclerosis and/or those recruited from outpatient clinics at participating centers.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

educational healthcare intervention
Other intervention
This intervention will be applyed at the beginning of the study
Objective assessment of GI motility
Diagnostic test
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
Diagnostic test
Objective evaluation of GERD severity on PPI therapy will be performed.

Treatment groups

147 Participants

are divided into 1 treatment group

Group A: patients with SSc and PPI-refractory GERD symptoms3 interventions

Trial outcomes

Primary outcomes

Prevalence of PPI-refractory GERD

The presence of erosive esophagitis B,C, or D on endoscopy, acid exposure time \> 4% or \> 80 reflux episodes, as per Lyon 2.0 criteria, will be considered refractory GERD.

Time frame

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

Secondary outcomes

Gastrointestinal dysmotility associations

prevalence of delayed gastric emptying, esophageal dysmotility and small bowel dysmotility.

Time frame

After 8 weeks on double PPI therapy, during week 8 to 12.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Universitari Vall d'Hebron Research Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: