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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects WITH nickel-sensitivity | Experimental | Subjects on nickel-free diet who have a positive patch-test result, indicating nickel-sensitivity. |
|
| Subjects WITHOUT nickel-sensitivity | Active Comparator | Subjects on nickel-free diet who have a negative patch-test result, indicating they do NOT have nickel-sensitivity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nickel-free diet | Other | Subjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WVU Medicine University Town Center | Morgantown | West Virginia | 26501 | United States | ||
| Physician's Office Center at Ruby Memorial, Digestive Diseases |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33219986 | Derived | Yousaf A, Hagen R, Mitchell M, Ghareeb E, Fang W, Correa R, Zinn Z, Gayam S. The effect of a low-nickel diet and nickel sensitization on gastroesophageal reflux disease: A pilot study. Indian J Gastroenterol. 2021 Apr;40(2):137-143. doi: 10.1007/s12664-020-01090-3. Epub 2020 Nov 21. |
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We do not plan to make IPD available to other researchers.
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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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.
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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.
| Morgantown |
| West Virginia |
| 26506 |
| United States |
| D004066 | Digestive System Diseases |