Effect of a Nickel Free Diet and Nickel Sensitization on GERD Patients.

Study Overview
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Brief Summary
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There is little evidence on the effect of a nickel-free diet on gastroesophageal reflux disease (GERD). We hope to determine if a nickel-free diet improves GERD symptoms in patients with a nickel allergy by having patients complete a questionnaire on their GERD symptoms before and after initiation of 8 weeks on a nickel-free diet.

Official Title
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Effect of a Nickel Free Diet and Nickel Sensitization on GERD Patients.

Conditions
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Gastroesophageal Reflux

Intervention / Treatment
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* Other: Nickel-free diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older with a history of GERD owns a phone with a camera has access to or is willing to sign up for MyChart is symptomatic for GERD at time of visit as determined by a score of >12 on the GERD Health Related Quality of Life (GERD-HRQL) questionnaire. (Patients that are currently taking a proton pump inhibitor (PPI) they must have been on the PPI for at least 3 months.) Exclusion Criteria: less than 18 years of age no not have access to MyChart are not willing to sign up for MyChart have taken an oral steroid within 4 weeks have experienced a sunburn or had significant sun exposure within the last 4 weeks, or applied a topical steroid to the area that the past test will be applied (i.e. upper back or arm) in the last 4 weeks. No vulnerable populations will be included.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will undergo a patch test to determine if they are hypersensitive to nickel among other metabolites. Regardless of the results of the patch test, patients will be placed on a nickel-free diet for 8 weeks.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects WITH nickel-sensitivity<br>Subjects on nickel-free diet who have a positive patch-test result, indicating nickel-sensitivity. | Other: Nickel-free diet<br>* Subjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects.<br>|
| Active Comparator: Subjects WITHOUT nickel-sensitivity<br>Subjects on nickel-free diet who have a negative patch-test result, indicating they do NOT have nickel-sensitivity. | Other: Nickel-free diet<br>* Subjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline Gastroesophageal reflux disease-Health Related Quality of Life (GERD-HRQL) Questionnaire score | questionnaire to assess severity of GERD. Total Score: Calculated by summing the individual scores to questions 1-12. Greatest possible score (worst symptoms) = 60; Lowest possible score (no symptoms) = 0. For the purposes of our study, a score of 13 or above is considered symptomatic for GERD. | after 8 weeks on nickel-free diet | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nickel-free, diet, GERD, Gastroesophageal Reflux