What side effects are associated with this type of intervention?

Common treatments for acid reflux include proton pump inhibitors (PPIs), H2 receptor antagonists (H2RAs), and dietary modifications. PPIs, which reduce stomach acid production, can cause side effects such as headache, diarrhea, constipation, nausea, and long-term risks like vitamin B12 deficiency and bone fractures. H2RAs, which also decrease acid production, may lead to headaches, dizziness, diarrhea, and constipation. Dietary modifications, such as those recommended by the Gracie Diet, generally have fewer side effects but require significant lifestyle changes and adherence to specific food combinations, which can be challenging for some patients.

What prior FDA approvals exist?

FDA-approved treatments for acid reflux primarily include proton pump inhibitors (PPIs) like omeprazole and esomeprazole, and H2 receptor antagonists (H2RAs) such as ranitidine. These medications reduce gastric acid secretion. While dietary modifications are recommended as a first-line therapy for GERD, specific diets like the Gracie Diet, which focuses on food combinations and meal spacing, are not FDA-approved treatments but are endorsed by health organizations for their potential benefits in managing GERD symptoms.

What other types of research exist?

Promising alternatives to the Gracie Diet for managing GERD symptoms include: 1) Low-FODMAP diet, which has been shown to reduce gastrointestinal symptoms in patients with inflammatory bowel disease and may benefit GERD patients. 2) Acupuncture, which has demonstrated efficacy in reducing refractory heartburn symptoms. 3) Continued use of proton pump inhibitors (PPIs) and H2 receptor antagonists, which remain the mainstay of GERD treatment. 4) Lifestyle modifications such as weight loss, smoking cessation, and avoiding alcohol and trigger foods. These alternatives should be discussed with a healthcare provider to tailor the best approach for individual patients.

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Gracie Diet for Acid Reflux

Q: What is the mechanism of action of this treatment?

The most common treatments for Acid Reflux include dietary modifications, proton pump inhibitors (PPIs), and H2 receptor antagonists (H2RAs). Dietary modifications, such as those proposed by the Gracie Diet, aim to improve digestion and reduce GERD symptoms by promoting the consumption of proper food combinations and avoiding foods that trigger acid production and fermentation. This approach helps prevent the chemical reactions in the digestive process that can lead to heartburn and regurgitation. PPIs work by potently inhibiting gastric acid secretion, thereby reducing acid reflux and healing the esophagus. H2RAs decrease gastric acid secretion by blocking histamine H2 receptors on gastric parietal cells. These treatments are crucial for Acid Reflux patients as they help manage symptoms, improve quality of life, and prevent complications associated with chronic acid exposure.

N/A

Recruiting

Led By Pankaj Pasricha, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age 18 years or older at registration

Must not have

A prior surgery of the upper gastrointestinal tract

Age < than 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 2 and week 4

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the Gracie Diet, which involves specific food combinations and meal spacing, to help people with GERD who don't get better with usual medications. The diet aims to improve digestion and reduce symptoms by preventing bad chemical reactions in the stomach.

Who is the study for?

This trial is for adults over 18 with ongoing GERD symptoms like heartburn and regurgitation, who are already taking PPIs or H2 blockers. It's not for those who can't speak English, have had upper GI surgery, are pregnant/nursing, or have other conditions that might affect their participation.

What is being tested?

The Gracie Diet is being tested as a potential alternative to improve GERD symptoms in patients unresponsive to standard doses of PPIs and/or H2 receptor antagonists. The diet focuses on food combinations to prevent digestive issues like fermentation and acidity.

What are the potential side effects?

While the study doesn't list specific side effects of the Gracie Diet, changes in diet may lead to initial discomfort such as bloating or changes in bowel habits as the body adjusts to new eating patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently taking a PPI or H2 blocker medication.

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I am 18 years old or older.

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I experience symptoms like heartburn, chest pain, or difficulty swallowing due to GERD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had surgery on my upper stomach area before.

Select...

I am under 18 years old.

Select...

I am unable to communicate in English.

Select...

I have difficulty swallowing that could lead to choking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 2 and week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 2 and week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 2 and week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in GERD medication

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

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

+3 more

Secondary study objectives

Change in Body Mass Index (BMI)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gracie DietExperimental Treatment1 Intervention

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

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acid Reflux include dietary modifications, proton pump inhibitors (PPIs), and H2 receptor antagonists (H2RAs). Dietary modifications, such as those proposed by the Gracie Diet, aim to improve digestion and reduce GERD symptoms by promoting the consumption of proper food combinations and avoiding foods that trigger acid production and fermentation. This approach helps prevent the chemical reactions in the digestive process that can lead to heartburn and regurgitation. PPIs work by potently inhibiting gastric acid secretion, thereby reducing acid reflux and healing the esophagus. H2RAs decrease gastric acid secretion by blocking histamine H2 receptors on gastric parietal cells. These treatments are crucial for Acid Reflux patients as they help manage symptoms, improve quality of life, and prevent complications associated with chronic acid exposure.