Physiology of GERD and Treatment Response

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    University of California, Davis
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Updated on 16 February 2024
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reflux
heartburn
acidity
acid reflux / gastroesophageal reflux

Summary

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

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.

Details
Condition Gastroesophageal Reflux
Age 24years - 64years
Treatment Amitriptyline
Clinical Study IdentifierNCT04292470
SponsorUniversity of California, Davis
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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