An observational study in Gastroesophageal Reflux, sponsored by Hospital de Clinicas José de San Martín. Completed at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by Hospital de Clinicas José de San Martín · Observational
Gastroesophageal reflux disease (GERD) is extremely common in our environment. Its diagnosis is complex. The Lyon Consensus defined, based on 24-hour pH monitoring, that an acid exposure time greater than 6% is definitely abnormal, less than 4% is normal, and between 4 and 6% is a gray area.
The objective of this study is to describe the change in therapeutic behavior based on the result of prolonged pH recording performed with a 96-hour wireless pH measurement capsule in patients with GERD symptoms and an acid exposure time measured by impedanciometry/pH of 24 hours in the gray area. Also, describe the therapeutic outcomes.
Thirty consecutive patients with GERD symptoms and an acid exposure time (AET) measured by impedance measurement/pH between 4 and 6% will be included.
A 96-hour off IBP wireless pH monitoring capsule will be performed. The worst day, the average of the 4 days and the presence of 2 or more days with AET>6% and the 4 days with AET\<4% will be recorded.
Patients will be categorized into GERD, reflux hypersensitivity, and functional heartburn. A treatment will be established based on these categories and the GERDq will be measured at 8 weeks of treatment.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 30 is below the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Hospital de Clinicas José de San Martín is the lead sponsor of 10 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients ≥ 18 years of age, with symptoms of Gastroesophageal Reflux, who have undergone a 24-hour impedance pH study without Proton Pump Inhibitors (PPIs), whose AET is between 4 and 6% will be included consecutively. .
Exclusion Criteria:
Thirty consecutive patients with GERD symptoms and an acid exposure time (AET) measured by impedance measurement/pH between 4 and 6% will be included.
Device: 96-hour off IBP wireless pH monitoring capsule
The endoscopic pH measurement capsule will be placed 6cm above the squamocolumnar junction, determined endoscopically, in the sedated patient. Then the plot will be read.
GERD Proportion
estimate the proportion of GERD measured by wireless pH monitoring capsule in patients in the gray area
Time frame: june 2021-june 2023
Therapeutic response
To compare the GERDq scale before and after treatment with proton pump inhibitors.
Time frame: june 2021-june 2023
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Hospital de Clinicas José de San Martín