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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Other: Nickel-free diet

• Registration Number: NCT03720756
• Lead Sponsor: West Virginia University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-05
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Study Start: 2019-01-03
• Primary Completion: 2020-01-31
• Study Completion: 2020-02-20
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects WITH nickel-sensitivity	Nickel-free diet	Subjects on nickel-free diet who have a positive patch-test result, indicating nickel-sensitivity.
Subjects WITHOUT nickel-sensitivity	Nickel-free diet	Subjects on nickel-free diet who have a negative patch-test result, indicating they do NOT have nickel-sensitivity.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

WVU Medicine University Town Center; 🇺🇸 Morgantown, West Virginia, United States

Physician's Office Center at Ruby Memorial, Digestive Diseases; 🇺🇸 Morgantown, West Virginia, United States