Mast Cells in Eosinophilic Esophagitis

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-005899
    Sponsor Protocol Number: 16-005899

About this study

Part 1 of the study will retrospectively compare the role of mast cells in children versus adult EoE patients based on the peak mast cell density.  Children with EoE have been shown to have more mast cell mediator-type of symptoms (vomiting, abdominal pain) than that of adults (solid food dysphagia).  We hypothesize a greater peak mast cell density in the esophageal biopsies of children than in adults with EoE. The group (children or adults) which show greater peak mast cell density will be the group for Part 2 of the study.

 

Part 2 of the study will prospectively compare the role of mast cells in EoE patients (either children or adults, based on Part 1 study). Histamine mediators, including serum tryptase and 24 hour urine beta-prostaglandin, N-methylhistamine, and leukotriene E4, will be obtained close to the time of obtaining esophageal biopsies.  Further analysis will determine  if there is a correlation between histamine release and peak mast cell density in the esophageal biopsies.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Eosinophilic esophagitis patients evaluated at Mayo Clinic will be the source of patients for this study.

Part 1:

20 children and 20 adult eosinophilic esophagitis patients will be retrospectively reviewed for the following:

  1. Patient demographics including age, sex, race

  2. EoE patient symptoms: dysphagia, food impaction, atopy (asthma, allergic rhinitis, eczema, IgE-mediated food allergies)

  3. Mast cell symptoms: flushing, pruritus, urticaria, abdominal cramping with diarrhea

  4. Comorbid mast cell disorder diagnosis

  5. If performed: Baseline tryptase and 24 hour urine studies: beta-prostaglandin, N-methylhistamine, and leukotriene E4

  6. Concurrent medications which histamine mediators: antihistamines, montelukast, aspirin

  7. EoE Rx (Concurrent medications which influence esophageal eosinophilia): PPI, steroids, elimination diet

  8. Endoscopic findings (rings, furrows)

 

Esophageal biopsies will further be analyzed based on tryptase staining for mast cells and then low and peak mast cells/HPF will be identified for the esophageal biopsies. Also, peak eosinophils/HPF will be identified in the esophageal biopsies with H&E staining.

 

Part 2:

The group with higher mast cells/HPF will be the cohort for Part 2 of the study.

At least 20 eosinophilic esophagitis patients will be prospectively reviewed for the following:

  1. Patient demographics including age, sex, race

  2. EoE patient symptoms: dysphagia, food impaction, atopy (asthma, allergic rhinitis, eczema, IgE-mediated food allergies)

  3. Mast cell symptoms: flushing, pruritus, urticaria, abdominal cramping with diarrhea

  4. Comorbid mast cell disorder diagnosis

  5. Baseline tryptase and 24 hour urine studies: beta-prostaglandin, N-methylhistamine, and leukotriene E4

  6. Concurrent medications which histamine mediators: antihistamines, montelukast, aspirin

  7. EoE Rx (Concurrent medications which influence esophageal eosinophilia): PPI, steroids, elimination diet

  8. Endoscopic findings (rings, furrows)

 

Esophageal biopsies will further be analyzed based on tryptase staining for mast cells and then low and peak mast cells/HPF will be identified for the esophageal biopsies. Peak eosinophils/HPF will be identified in the esophageal biopsies with H&E staining.

 

We aim to see if there is an elevated histamine release (via serum tryptase and 24 hour urine N-methyl histamine, beta-prostaglandin, and leukotriene E4) in EoE patients and further correlated with density of tryptase staining on esophageal biopsies.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Anupama Ravi, M.D.

Contact us for the latest status

Contact information:

Debra Geno CCRP

(507)538-0367

Geno.Debra@mayo.edu