ACTIVE_NOT_RECRUITING

Gracie Diet for Gastroesophageal Reflux Disease

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Conditions

Gastroesophageal RefluxGERDDietReflux

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if dietary changes can help improve gastroesophageal reflux disease (GERD) symptoms. The main question\[s\] it aims to answer whether the Gracie Diet is an option to treat GERD symptoms in individuals wish to discontinue standard doses of PPI and / or H2 receptor antagonists. Participants will be taken off PPI and be placed on the Gracie Diet for 8 weeks. Information about the participants reflux symptoms and GERD health related quality of life will be collected to assess the effect of the diet.

Official Title

Gracie Diet for Gastroesophageal Reflux Disease

Quick Facts

Study Start:2020-11-13
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04360252

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older at registration.
  2. * Patients with ongoing symptoms of GERD: heartburn (pyrosis) mid-sternal chest pain, regurgitation of fluid or food, development of esophageal inflammation that may lead to swallowing dysfunction, or extraesophageal manifestations (i.e. cough, bronchospasms, and hoarseness).
  3. * Use of one of the following PPI medications: omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole or dexlansoprazole. And/or use of one of the following H2 blockers medications as well: famotidine, cimetidine, ranitidine or nizatidine.
  4. * Willing to comply with the Gracie diet regimen
  1. * Age \< than 18 years.
  2. * Patients unable to speak English.
  3. * Pregnancy or nursing.
  4. * Complicated oropharyngeal dysphagia or other condition with risk for aspiration from oral ingestion.
  5. * Exclusion of other causes of symptoms as mechanical gastrointestinal obstruction, Barrett's esophagus and cancer of the esophagus by standard radiographic or endoscopic test evidenced in the medical record chart.
  6. * A prior surgery of the upper gastrointestinal tract.
  7. * Failure to give informed consent.
  8. * Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study.

Contacts and Locations

Principal Investigator

Robert Bulat, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Robert Bulat, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-13
Study Completion Date2027-12

Study Record Updates

Study Start Date2020-11-13
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • GERD
  • Diet
  • Reflux

Additional Relevant MeSH Terms

  • Gastroesophageal Reflux
  • GERD