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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-03

Study Completion Date

2020-02-20

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.

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Detailed Description

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Conditions

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Gastroesophageal Reflux

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The efficacy of treatment methods will be assessed by comparing GERD-Health Related Quality of Life (HRQL) questionnaires before and after implementation of a nickel-free diet.

Study Groups

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Subjects WITH nickel-sensitivity

Subjects on nickel-free diet who have a positive patch-test result, indicating nickel-sensitivity.

Group Type EXPERIMENTAL

Nickel-free diet

Intervention Type OTHER

Subjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects.

Subjects WITHOUT nickel-sensitivity

Subjects on nickel-free diet who have a negative patch-test result, indicating they do NOT have nickel-sensitivity.

Group Type ACTIVE_COMPARATOR

Nickel-free diet

Intervention Type OTHER

Subjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects.

Interventions

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Nickel-free diet

Subjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes