CompletedNot Applicable

Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease

United States47 participantsStarted 2006-10

Plain-language summary

The purpose of this study is to establish the clinical application of a new device that records pH changes in the hypopharynx. The investigators also aim to compare the consistency of distal esophageal pH with hypopharyngeal pH using both the "short" and the "long" catheters in patients.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male and female volunteers aged 18 to 65 years old.
✓. Control group: No known history of GERD or EERD or prior PPI use.
✓. GERD group: Patients with known history of GERD based on prior response to either histamine inhibitors (H2 blockers) or proton pump inhibitors (PPIs) and/or endoscopic esophagitis identified at endoscopy.
✓. EERD group: Patients with chronic cough, asthma and laryngeal findings felt to be GERD related.

Exclusion criteria

✕. Use of H2 blockers or PPIs within one week prior to and during the study for the GERD and EERD patients. No prior PPI use is allowed for the control population.
✕. Use of antacids (Rolaids, Tums, Pepto-Bismol, etc.) within one day prior to or during the study.
✕. Esophageal motility abnormalities (achalasia, esophageal spasm, severe dysphagia)
✕. Expected non-compliance.
✕. Positive history of ongoing alcohol or tobacco use and inability to refrain from using either during study duration (24 hours).
✕. Recent nasal surgery or nasal obstruction.
✕. Significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety (mental disability, psychiatric impairment, inability to read or comprehend the consent form)

What they're measuring

Decrease in pH From Baseline to <4

Timeframe: 24 hours

Decrease in pH From Baseline to <5

Timeframe: 24 hours

Decrease in pH From Baseline to <6

Timeframe: 24 hours

Trial details

NCT IDNCT00388453

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-09

Results submitted2016-03-10

View on ClinicalTrials.gov More GERD trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male and female volunteers aged 18 to 65 years old.
✓. Control group: No known history of GERD or EERD or prior PPI use.
✓. GERD group: Patients with known history of GERD based on prior response to either histamine inhibitors (H2 blockers) or proton pump inhibitors (PPIs) and/or endoscopic esophagitis identified at endoscopy.
✓. EERD group: Patients with chronic cough, asthma and laryngeal findings felt to be GERD related.

Exclusion criteria

✕. Use of H2 blockers or PPIs within one week prior to and during the study for the GERD and EERD patients. No prior PPI use is allowed for the control population.
✕. Use of antacids (Rolaids, Tums, Pepto-Bismol, etc.) within one day prior to or during the study.
✕. Esophageal motility abnormalities (achalasia, esophageal spasm, severe dysphagia)
✕. Expected non-compliance.
✕. Positive history of ongoing alcohol or tobacco use and inability to refrain from using either during study duration (24 hours).
✕. Recent nasal surgery or nasal obstruction.
✕. Significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety (mental disability, psychiatric impairment, inability to read or comprehend the consent form)