Gastroesophageal Reflux
Conditions
Keywords
nickel-free, diet, GERD, Gastroesophageal Reflux
Brief summary
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.
Interventions
OTHERNickel-free diet
Subjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects.
Sponsors
West Virginia University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline Gastroesophageal reflux disease-Health Related Quality of Life (GERD-HRQL) Questionnaire score | after 8 weeks on nickel-free diet | 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. |
Countries
United States
Outcome results
None listed