Correlates of GERD Symptom Severity



Status:Recruiting
Conditions:Gastroesophageal Reflux Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:21 - 70
Updated:3/1/2019
Start Date:May 22, 2017
End Date:January 2020
Contact:Emma Needles
Email:eneedles@partners.org
Phone:617-643-6062

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Physiologic and Behavioral Correlates of GERD Symptom Severity

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

Subjects will complete questionnaires regarding their GERD-related symptoms and have a visit
with a study clinician regarding their symptoms. We will measure heart rate variability and
galvanic skin response in patients during the visits and video record the visits. Subjects
will complete a daily GERD symptom diary for 2 weeks and then return to the study center to
complete additional questionnaires and an exit interview.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-6062
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mi
from
Boston, MA
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