Correlates of GERD Symptom Severity

Completed

Conditions studied: GERD

In brief

This is a pilot study measuring physiologic and behavioral correlates of symptom severity in adult patients with gastroesophageal reflux disease (GERD).

Key facts

Study ID

NCT03020550

Run by

Massachusetts General Hospital

People needed

24

Starts

2017-05-22

Expected to finish

2019-05-07

Last updated by the study team

2021-01-15

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults ages 21-70 years old
• Heartburn symptoms 3 or more days per week with an average daily symptom severity of 3 or more on a 7 day baseline symptom diary
• English language proficiency
• Willingness to be videotaped and connected to physiologic monitoring devices during the visit

You may not qualify if…

• Diagnosis of Crohn's disease, systemic sclerosis, known active ulcer disease, gastric cancer, or untreated/active Barrett's esophagitis based on subject self-report and/or medical record review
• Heavy alcohol use (> 6 drinks/week for women and > 13 drinks/week for men)
• Pregnant women.
• Dementia or significant memory difficulties
• Severe, unstable psychiatric disease
• Greater than 15 doses of nonsteroidal anti-inflammatory drugs (NSAIDS) within the prior 30 days (aspirin ≤ 325 mg daily permitted) or ongoing NSAID use at a level deemed likely to interfere with the study
• Failure to complete the baseline symptom diary for at least 6 of 7 days
• Change in GERD treatment regimen within the last 2 weeks (subjects may use antacids, H2 receptor blockers, and/or proton pump inhibitors as long as they are symptomatic on a stable regimen)
• Allergy to adhesives
• Inability to provide informed consent

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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