NCT02775045

Brief Summary

The purpose of this study is to improve the overall management of patients with Eosinophil Esophagitis. Currently, the best way to monitor Eosinophil Esophagitis is repeating the endoscopy procedure. The investigators plan to identify a biomarker in the blood (a measurable substance) that tracks with disease activity and will reduce the need for follow-up endoscopies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 30, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2018

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

2.3 years

First QC Date

May 13, 2016

Last Update Submit

January 29, 2019

Conditions

Eosinophilic Esophagitis

Keywords

EoE

Outcome Measures

Primary Outcomes (1)

  • Eosinophil Esophagitis symptom score

    8 weeks

Study Arms (1)

Eosinophil esophagitis

Adult patients (\>18 yr) will be recruited from the Gastroenterology clinic following a diagnostic endoscopy for esophageal dysfunction with predominant symptom(s) of solid food dysphagia and/or esophageal food impaction. Patients with esophageal biopsy showing greater than 15 eosinophil/hpf (pathology results typically available within three business days) despite greater than two months use of high dose proton pump inhibitor will be invited to participate and enroll in the study within 1 week of the endoscopy.

Other: Observation Period

Interventions

Observation PeriodOTHER

8 week observational period

Eosinophil esophagitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients (\>18 yr) will be recruited from the Gastroenterology clinic following a diagnostic endoscopy for esophageal dysfunction with predominant symptom(s) of solid food dysphagia and/or esophageal food impaction. Patients with esophageal biopsy showing greater than 15 EOS/hpf (pathology results typically available within three business days) despite greater than two months use of high dose proton pump inhibitor will be invited to participate and enroll in the study within 1 week of the endoscopy.

You may qualify if:

  • Male or female with no health concerns that might affect the outcome of the study,
  • Age 18 years of age and older
  • Esophageal dysfunction with a predominant symptom of solid food dysphagia and/or esophageal food impaction
  • Esophageal eosinophilia (\>15 eosinophils/HPF) shown on biopsy
  • In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements.

You may not qualify if:

  • Pregnant or lactating females or has a planned pregnancy during the course of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW Madison School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

  • Bartig KA, Lee KE, Mosher DF, Mathur SK, Johansson MW. Platelet association with leukocytes in active eosinophilic esophagitis. PLoS One. 2021 Apr 23;16(4):e0250521. doi: 10.1371/journal.pone.0250521. eCollection 2021.

    PMID: 33891621DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

55 mL of blood will be drawn during V1 and V2. The blood will be drawn to save serum, for flow cytometry to answer the research questions, to isolate plasma and purify eosinophils for banking of whole cell protein and RNA, and to allow for genetic analysis of DNA. DNA will be isolated for directed genetic analysis of genes related to eosinophil biology and inflammation associated with EoE. Currently, these include ORMDL3, eotaxin-3, and IL-13 and may include others upon identification in the literature. This limited analysis is not expected to be sufficient for subject identification nor is it expected that the genes will be predictive of any other disease process. The genetic portion of the blood draw will not be optional.

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Sameer Mathur, MD/PhD

    UW Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 17, 2016

Study Start

August 30, 2016

Primary Completion

December 13, 2018

Study Completion

December 13, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

Locations

US(1)