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

Primary Purpose

Gastroesophageal Reflux

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nickel-free diet
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring nickel-free, diet, GERD, Gastroesophageal Reflux

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • WVU Medicine University Town Center
  • Physician's Office Center at Ruby Memorial, Digestive Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Subjects WITH nickel-sensitivity

Subjects WITHOUT nickel-sensitivity

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2018
Last Updated
September 1, 2020
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT03720756
Brief Title
Effect of a Nickel Free Diet and Nickel Sensitization on GERD Patients.
Official Title
Effect of a Nickel Free Diet and Nickel Sensitization on GERD Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
nickel-free, diet, GERD, Gastroesophageal Reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
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.
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects WITH nickel-sensitivity
Arm Type
Experimental
Arm Description
Subjects on nickel-free diet who have a positive patch-test result, indicating nickel-sensitivity.
Arm Title
Subjects WITHOUT nickel-sensitivity
Arm Type
Active Comparator
Arm Description
Subjects on nickel-free diet who have a negative patch-test result, indicating they do NOT have nickel-sensitivity.
Intervention Type
Other
Intervention Name(s)
Nickel-free diet
Intervention Description
Subjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects.
Primary Outcome Measure Information:
Title
Change in baseline Gastroesophageal reflux disease-Health Related Quality of Life (GERD-HRQL) Questionnaire score
Description
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.
Time Frame
after 8 weeks on nickel-free diet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
WVU Medicine University Town Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26501
Country
United States
Facility Name
Physician's Office Center at Ruby Memorial, Digestive Diseases
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to make IPD available to other researchers.
Citations:
PubMed Identifier
33219986
Citation
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.
Results Reference
derived

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

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