Dietary changes for treating gastroesophageal reflux disease
Gracie Diet for Gastroesophageal Reflux Disease
This study is testing if following the Gracie Diet for 8 weeks can help people with gastroesophageal reflux disease (GERD) feel better and possibly stop using their usual medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04360252 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether the Gracie Diet can improve symptoms of gastroesophageal reflux disease (GERD) in patients who wish to discontinue standard medications like proton pump inhibitors (PPIs) and H2 receptor antagonists. Participants will follow the Gracie Diet for 8 weeks, during which their reflux symptoms and quality of life related to GERD will be monitored. The study aims to determine if dietary modifications can serve as an effective treatment option for GERD.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with ongoing GERD symptoms who are currently using PPIs or H2 blockers.
Not a fit: Patients under 18, those unable to speak English, or individuals with complicated swallowing issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological treatment option for patients suffering from GERD.
How similar studies have performed: Other studies have supported dietary modifications as a first-line therapy for GERD, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older at registration. * 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). * 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. * Willing to comply with the Gracie diet regimen Exclusion Criteria: * Age \< than 18 years. * Patients unable to speak English. * Pregnancy or nursing. * Complicated oropharyngeal dysphagia or other condition with risk for aspiration from oral ingestion. * 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. * A prior surgery of the upper gastrointestinal tract. * Failure to give informed consent. * Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Robert Bulat, MD — Johns Hopkins University
- Study coordinator: Robert Bulat, MD
- Email: rbulat1@jhmi.edu
- Phone: 410-550-2060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.