Gracie Diet for Gastroesophageal Reflux Disease

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04360252
Study type	Interventional
Source	Johns Hopkins University
Contact	Robert Bulat, MD
Phone	410-550-2060
Email	rbulat1@jhmi.edu
Status	Recruiting
Phase	N/A
Start date	November 13, 2020
Completion date	December 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05561179` - Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease	N/A
Withdrawn	`NCT02213887` - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications	Phase 4
Completed	`NCT01946971` - Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)	Phase 1/Phase 2
Recruiting	`NCT01825473` - Study of Erythromycin in GER-Associated Apnea of the Newborn	N/A
Completed	`NCT00614536` - Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period	Phase 4
Completed	`NCT00284908` - Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers	Phase 1
Completed	`NCT00373997` - Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux	Phase 4
Completed	`NCT00365300` - Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)	Phase 3
Completed	`NCT00291746` - Validation of RDQ Questionnaire	Phase 4
Completed	`NCT00567021` - German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms	N/A
Completed	`NCT01167543` - Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease	N/A
Completed	`NCT00215787` - Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease	N/A
Completed	`NCT00141960` - Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease	Phase 2/Phase 3
Completed	`NCT00226044` - Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.	Phase 3
Completed	`NCT00181805` - Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
Completed	`NCT01048840` - Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
Terminated	`NCT01281553` - A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease	Phase 4
Completed	`NCT05486169` - Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy	N/A
Completed	`NCT04034017` - Gastroesophageal Reflux Disease Among College Students
Terminated	`NCT03226054` - Determining Risk Factors for Successful PPI Weaning	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.