Clinical trial NCT04360252: Gracie Diet for Gastroesophageal Reflux Disease
Official title: Gracie Diet for Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastroesophageal Reflux
GERD
Keywords: GERD
Diet
Reflux
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Change in University of California Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0) score
timeFrame: Baseline, week 2 and week 4
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) scale score
timeFrame: Baseline, week 2 and week 4
measure: Change in the Reflux Symptoms Index (RSI) score
timeFrame: Baseline, week 2 and week 4
measure: Change in the Health-related Quality Of Life scale for GERD (GERD-HRQL) score
timeFrame: Baseline, week 2 and week 4
measure: Change in the Gracie Diet adherence as assessed by a patient diary inventory
timeFrame: Daily up to 4 weeks
measure: Change in GERD medication
timeFrame: Baseline, week 2 and week 4
Secondary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, week 2 and week 4
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Robert Bulat, MD
role: PRINCIPAL_INVESTIGATOR
References: