Gracie Diet for Gastroesophageal Reflux Disease

NCT04360252 | Active Not Recruiting

• 1 other identifier: IRB00248899
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux; GERD

Keywords

GERD; Diet; Reflux

Outcome Measures

Primary Outcomes (6)

• Change in University of California Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0) score

  The effect of the Gracie Diet in GERD symptoms by changes in the UCLA SCTC GIT 2.0 score. The UCLA-SCTC GIT 2.0 is a multi-item instrument that measures GI symptoms and the impact on health related quality of life. Includes 34 questions in 7 domains (reflux, distension, soilage, diarrhea, social function, emotional wellbeing and constipation) during a 7 day recall period. Each domain is weighted and scored, and a total score is then calculated.

  Baseline, week 2 and week 4

• Change in Patient Reported Outcomes Measurement Information System (PROMIS) scale score

  The effect of the Gracie Diet in GERD symptoms by changes in the PROMIS Scale score. This questionnaire has items that measure the frequency, severity, impact, and bother of cardinal GERD symptoms, including heartburn and regurgitation, using a seven-day recall period. The questionnaire consists of 13 questions, and in each question, the answers are scored from 0 to 5.

  Baseline, week 2 and week 4

• Change in the Reflux Symptoms Index (RSI) score

  The effect of the Gracie Diet in GERD symptoms by changes in the RSI score. The RSI is a nine-item questionnaire assessing symptom severity, and designed to assess the severity of symptoms related to laryngopharyngeal reflux. Normative data suggests that a RSI of greater than or equal to 13 is clinically significant. Therefore a RSI \> 13 may be indicative of significant reflux disease.

  Baseline, week 2 and week 4

• Change in the Health-related Quality Of Life scale for GERD (GERD-HRQL) score

  The effect of Gracie Diet in GERD symptoms by changes in the score of the GERD - HRQL. The GERD-HRQL was developed to survey symptomatic outcomes and therapeutic effects in patients with GERD. The scale has 11 items, which focus on heartburn symptoms, dysphagia, medication effects and the patient's present health condition. The GERD-HRQL takes approximately one minute to complete. Each item is scored from 0 to 5, with a higher score indicating a better QOL.

  Baseline, week 2 and week 4

• Change in the Gracie Diet adherence as assessed by a patient diary inventory

  Assess adherence to diet through the use of a diary where the patient can track the food eaten during the day.

  Daily up to 4 weeks

• Change in GERD medication

  The effect of Gracie Diet in medication intake through a review of the medication list, dose and intake frequency.

  Baseline, week 2 and week 4

Secondary Outcomes (1)

• Change in Body Mass Index (BMI)

  Baseline, week 2 and week 4

Study Arms (1)

Gracie Diet

EXPERIMENTAL

Patients will have a nutritional consultation and will follow the Gracie diet for a month.

Other: Gracie Diet

Interventions

Gracie Diet OTHER

The patient is going to have an encounter with the nutritionist (either face to face or by phone call) and she will provide patient with the requisite nutritional information and will guide patient on how to properly adhere to the diet. The session is designed to: answer patient questions, educate patients so that patients understand the underlying nutritional concepts that the diet is based upon, support patients by empowering the patients to make healthy nutritional choices consistent with the diet, educate patients regarding the appropriate combinations of healthy foods, and help patients to develop menu samples based on the Gracie Diet when there is interest.

Gracie Diet

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Robert Bulat, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 24, 2020
• Study Start: November 13, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)