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

NCT03720756 | Completed

• 1 other identifier: 1804080531
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Gastroesophageal Reflux

Keywords

nickel-free; diet; GERD; Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Subjects WITH nickel-sensitivity

EXPERIMENTAL

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

Other: Nickel-free diet

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.

Other: Nickel-free diet

Interventions

Nickel-free diet OTHER

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

Subjects WITH nickel-sensitivity; Subjects WITHOUT nickel-sensitivity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (2)

WVU Medicine University Town Center

Morgantown, West Virginia, 26501, United States

Location

Physician's Office Center at Ruby Memorial, Digestive Diseases

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• 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.

  PMID: 33219986 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, Assistant Professor of Dermatology

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 25, 2018
• Study Start: January 3, 2019
• Primary Completion: January 31, 2020
• Study Completion: February 20, 2020
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)