Gracie Diet for Gastroesophageal Reflux Disease

Last updated: January 15, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Heartburn (Pediatric)

Treatment

Gracie Diet

Clinical Study ID

NCT04360252
IRB00248899
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 leadto 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 H2blockers medications as well: famotidine, cimetidine, ranitidine or nizatidine.

  • Willing to comply with the Gracie diet regimen

Exclusion

Exclusion Criteria:

  • Age < than 18 years.

  • Patients unable to speak English.

  • Pregnancy or nursing.

  • Complicated oropharyngeal dysphagia or other condition with risk for aspiration fromoral ingestion.

  • Exclusion of other causes of symptoms as mechanical gastrointestinal obstruction,Barrett's esophagus and cancer of the esophagus by standard radiographic orendoscopic 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 impedecompliance or hinder the completion of the study.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Gracie Diet
Phase:
Study Start date:
November 13, 2020
Estimated Completion Date:
December 31, 2025

Study Description

GERD, is a common and chronic world-wide disease. Cardinal symptoms of this condition are heartburn-regurgitation, and sometimes with extra-intestinal symptoms that can affect patients' quality of life. Proton pump inhibitors (PPIs) potently inhibit gastric acid secretion and are widely used for treatment of acid-related diseases. This class of medications is the most widely used for the management of GERD. H2 Receptor Antagonists (H2RAs) are another type of medication used to of uncomplicated GERD, gastric or duodenal ulcers, gastric hypersecretion, and for mild to infrequent heartburn or indigestion. H2RAs decrease gastric acid secretion by reversibly binding to histamine H2 receptors located on gastric parietal cells, thereby inhibiting the binding and action of the endogenous ligand histamine.

Dietary modification is endorsed by the National Institutes of Health and the American College of Gastroenterology as a first-line therapy for patients with GERD. The Gracie Diet is thought to play an important role in the prevention of GERD. The concept behind this diet is that the consumption of proper food combinations promotes optimal health by preventing unhealthy chemical reactions in the digestive process such as fermentation and acidity.

This diet describes the benefits of combining different foods together and the downsides of combining others. It provides guidance on avoiding specific foods and combinations of foods that may aggravate GERD, and adopting meal spacing habits to improve overall health outcomes. The idea is that such dietary changes support more efficient digestion and encourage healthier lifestyles (i.e. smoking cessation, elimination of alcohol intake, avoidance of soda consumption and desserts). This diet also supports the acquisition of healthy eating habits characterized by higher consumption of fruits, vegetables, and whole grains, and encourages a reduction in the intake of saturated fat, sodium, added sugars, and canned foods. Limiting beverage consumption of water or fresh coconut water between meals is also encouraged. In this pilot study, the investigators hypothesized that the Gracie diet it could be an alternative option to improve GERD symptoms in those patients who do not respond to standard doses of PPI and/or H2 receptor antagonists.

Connect with a study center

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

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