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Trial record 4 of 89405 for:    testing

Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis (EoE)

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ClinicalTrials.gov Identifier: NCT02227836
Recruitment Status : Completed
First Posted : August 28, 2014
Results First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Karthik Ravi, M.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE August 26, 2014
First Posted Date  ICMJE August 28, 2014
Results First Submitted Date  ICMJE March 1, 2019
Results First Posted Date  ICMJE April 17, 2019
Last Update Posted Date April 17, 2019
Study Start Date  ICMJE August 2014
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
Sensitivity of Patch Testing [ Time Frame: up to 120 hours after application of patch test ]
Sensitivity of the patch test will be defined by the number of subjects with total positive APT reactions correlated to histologic findings
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2014)
Reliability of patch testing is defined by the elimination of eosinophils in the esophagus with the endoscopic biopsies. [ Time Frame: basesline, six weeks, 10 weeks, 14, weeks, 18 weeks, 20 weeks, 22 weeks, 24 weeks ]
As a pilot, 20 patients will be studied to determine the reliability of the allergy patch test (APT) to predict dietary therapy. Reliability of the patch test and dietary therapy will be defined by the endoscopy biopsies.
Change History Complete list of historical versions of study NCT02227836 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis
Official Title  ICMJE Efficacy of Allergy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study
Brief Summary This study is being done to see if allergy patch testing (APT) can help predict effective dietary therapy in patients with eosinophilic esophagitis.
Detailed Description Patients are referred to Mayo Clinic Rochester with an establish diagnosis of EoE and are nonresponsive to proton pump inhibitor (PPI) medical therapy. Eligible patients will then meet with one of three investigators complete the Mayo Dysphagia Questionaire-30 Day (MDQ-30) following which a standardized Allergy Patch testing (APT) will be conducted. Thereafter, a standard clinically indicated Six Food Elimination Diet treatment completed. Patients will follow up with one of three investigators following the elimination diet who will be blinded to the results of the APT. During this visit responders and nonresponders will be identified and nonresponders will complete a directed elimination diet based on APT results.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Eosinophilic Esophagitis
Intervention  ICMJE Device: Allergy Patch Testing
Other Names:
  • APT
  • Patch testing
  • Allergy testing
Study Arms  ICMJE Experimental: Allergy Patch Testing APT

Patient will undergo APT testing per the following protocol:

  • 2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.
  • Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits
  • The patches will be removed at 48 hours, and results read at 72 and 120 hours after application
  • Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).
Intervention: Device: Allergy Patch Testing
Publications * Eckmann JD, Ravi K, Katzka DA, Davis DR, See JA, Geno DR, Kryzer LA, Alexander JA. Efficacy of Atopy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study. Dig Dis Sci. 2018 Mar;63(3):694-702. doi: 10.1007/s10620-018-4928-4. Epub 2018 Jan 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2016)
8
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2014)
20
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Adults ages 18-90
  • Patients with EoE, defined as dysphagia with histologic finding of greater than or equal to 15 eosinophils per high powered field (eos per HPF) on index esophageal biopsy
  • Persistent symptoms and/or greater than or equal to 10 eos per HPF on esophageal biopsy after at least 8 weeks of twice daily PPI therapy

Exclusion criteria:

  • Patients with conditions known to be associated with esophageal eosinophilia, including Crohn's disease, Churg-Strauss, achalasia, and hypereosinophilic syndrome
  • Topical swallowed steroids within 8 weeks of study enrollment
  • Dermatologic conditions precluding application of Finn chambers to the skin for APT
  • Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02227836
Other Study ID Numbers  ICMJE 14-002050
UL1TR000135 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Karthik Ravi, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karthik Ravi, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP