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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03720756
• Other study ID #: 1804080531
• Status: Completed
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: September 2020
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 20, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

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

Locations

Country	Name	City	State
United States	Physician's Office Center at Ruby Memorial, Digestive Diseases	Morgantown	West Virginia
United States	WVU Medicine University Town Center	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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