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Gracie Diet for Acid Reflux

N/A
Recruiting
Led By Robert Bulat, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 2 and week 4
Awards & highlights

Study Summary

This trial is testing whether the Gracie diet can help people with GERD who don't respond well to standard medication.

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.Check my eligibility
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.See study design
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
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change in Body Mass Index (BMI)

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.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,750 Total Patients Enrolled
Robert Bulat, MDPrincipal InvestigatorJohns Hopkins University
Pankaj Pasricha, MDPrincipal InvestigatorJohns Hopkins University
6 Previous Clinical Trials
292 Total Patients Enrolled

Media Library

Gracie Diet Clinical Trial Eligibility Overview. Trial Name: NCT04360252 — N/A
Acid Reflux Research Study Groups: Gracie Diet
Acid Reflux Clinical Trial 2023: Gracie Diet Highlights & Side Effects. Trial Name: NCT04360252 — N/A
Gracie Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT04360252 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial currently enrolling participants?

"Affirmative. According to the information found on clinicaltrials.gov, this medical trial has been accepting enrolment since November 13th 2020 and was last modified on March 8th 2022. It desires 20 patients from one site for participation in its research studies."

Answered by AI

Do participants over four decades of age fulfill the requirements for this clinical investigation?

"This trial is accessible to those aged 18-80. If the patient falls outside of this range, they may be eligible for one of 15 clinical trials intended for minors or 63 studies designed with elderly individuals in mind."

Answered by AI

How many participants are involved in the ongoing experiment?

"Confirmed. Per the information found on clinicaltrials.gov, this medical trial is actively seeking volunteers to participate in its research study. This experiment was initially posted on November 13th 2020 and most recently revised on March 8th 2022; 20 individuals are required at 1 site for enrolment purposes."

Answered by AI

Is entry into this medical trial open to me?

"This medical study seeks 20 individuals between the ages 18 to 80 who are struggling with gastroesophageal reflux. Essential eligibility criteria demand that those participating have taken either one of a group of proton-pump inhibitors (PPI) medicaments such as omeprazole, lansoprazole, pantoprazole etc., or any histamine 2 blockers medication like famotidine, cimetidine and so on; exhibit continuing manifestations of GERD including heartburn, sternum pain and regurgitation; consent to follow Gracie's dietary regimen."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Maryland
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins Bayview Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Gracie Diet for Gastroesophageal Reflux Disease
2020. "Gracie Diet for Gastroesophageal Reflux Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04360252.
All > Gerd
~4 spots leftby Dec 2024
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