Physiology of GERD and Treatment Response

University of California (UC) Davis

Status

Completed

Conditions

GERD

Treatments

Drug: Amitriptyline

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04292470

1485210

K23AT009218 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study is designed to assess the physiologic and behavioral mechanisms associated with enhanced medication effects in adult patients with functional GERD-related symptoms.

Full description

Subjects will complete questionnaires regarding their GERD-related symptoms and have a visit with a study clinician regarding their symptoms. Heart rate variability and galvanic skin response will be measured in the patient-provider dyads and the visits video recorded. Subjects will receive a two-month supply of amitriptyline (10 mg/day), along with instructions for taking it. Subjects will complete a daily GERD symptom diary during the first and eighth weeks of the study. At the end of the 8-week observation period, subjects will complete follow-up measures of GERD symptom severity and quality of life.

Enrollment

7 patients

Sex

All

Ages

24 to 64 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adults ages 24-64 years old
Functional heartburn (defined as <4% of time with reflux on 24 hour pH manometry) 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
Willingness to take amitriptyline daily for 8 weeks following study visit 1

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) based on subject self-report
Pregnant, attempting to become pregnant, or breast-feeding
Dementia or significant memory difficulties as determined by the study team and medical record review
Severe, unstable psychiatric disease based on subject self-report, study team determination, and/or medical record review
Bipolar disorder, concurrent treatment with a SSRI or another antidepressant that interacts with tricyclic antidepressants
Prolonged QTc or severe heart disease
History of seizure disorder
Severe liver impairment - e.g., cirrhosis, hepatocellular carcinoma, hepatitis
Currently taking a tricyclic antidepressant, allergy to tricyclic antidepressants, or another medical contraindication to taking amitriptyline or related medications
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
In the opinion of the investigator, unable to comply with the study protocol or has a condition that would likely interfere with the study