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Esophageal Absorption in EoE (EoE)

Primary Purpose

Eosinophilic Esophagitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
D-xylose
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Eosinophilic Esophagitis focused on measuring Eosinophilic Esophagitis, EoE, dysphagia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors or negative pH study
  • endoscopy with esophageal and duodenal biopsies within two weeks of performance of this study
  • Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors or negative pH study, and are now in histologic remission( <15phf) by the use of steroids or the six food elimination diet.
  • Volunteers will be selected for not having any history of esophageal symptoms

Exclusion Criteria:

  • Vulnerable populations, such as those with diminished mental acuity, will be excluded.
  • Patients taking Nsaids within 48 hours of the d-xylose testing
  • artificial sweeteners within 48 hours of the d-xylose testing
  • History of IBD
  • Currently smoking or history of smoking
  • History of Celiac disease
  • Bacterial overgrowth,
  • motility disorders
  • other diffuse small bowel diseases.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

D-xylose, water, honey

Arm Description

25 grams of D-xylose 10 cc of water 2 teaspoons of honey

Outcomes

Primary Outcome Measures

Reliability of the d-xylose testing defined by the serum levels
D-xylose serum levels will be drawn at 5 and 10 and 60 minutes. D-xylose levels will be compared between the patients with active EOE and healthy controls using the Wilcoxon rank sum test.

Secondary Outcome Measures

D-xylose testing compared to endoscopy/biopsy findings.
Histologic parameters will include grading of spongiosis as an indicator of dilated intercellular spaces which will be correlated to serum levels of D-xylose.

Full Information

First Posted
November 10, 2014
Last Updated
July 19, 2016
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02314455
Brief Title
Esophageal Absorption in EoE
Acronym
EoE
Official Title
Esophageal Absorption in Eosinophilic Esophagitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Early analysis showed negative results. It was decided to halt the study.
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine how the esophagus in active and inactive stages of eosinophilic esophagitis tranmit fluids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Esophagitis
Keywords
Eosinophilic Esophagitis, EoE, dysphagia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D-xylose, water, honey
Arm Type
Experimental
Arm Description
25 grams of D-xylose 10 cc of water 2 teaspoons of honey
Intervention Type
Other
Intervention Name(s)
D-xylose
Other Intervention Name(s)
Eosinophilic esophagitis, Absorption study
Intervention Description
There will be four patient groups analyzed. Ten patients each, 10 with active eosinophilic esophagitis defined by consensus guidelines, 20 patients in histologic remission (10 by steroids and 10 by diet) and 10 control volunteers will be studied. Patients who have consented to the trial will be scheduled at the Clinical Research Unit (CRU) Patients will report to Charlton 7 the CRU, having their height, weight, blood pressure and temperature recorded. Subjects can choose to either have a saline lock IV placed or have their bloods drawn 3 separate times. They will receive 25 grams of D-xylose orally. The D-xylose will be mixed in 10 cc of water with 2 teaspoons of honey. D-xylose serum levels will be drawn at 5 and 10 and 60 minutes.
Primary Outcome Measure Information:
Title
Reliability of the d-xylose testing defined by the serum levels
Description
D-xylose serum levels will be drawn at 5 and 10 and 60 minutes. D-xylose levels will be compared between the patients with active EOE and healthy controls using the Wilcoxon rank sum test.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
D-xylose testing compared to endoscopy/biopsy findings.
Description
Histologic parameters will include grading of spongiosis as an indicator of dilated intercellular spaces which will be correlated to serum levels of D-xylose.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors or negative pH study endoscopy with esophageal and duodenal biopsies within two weeks of performance of this study Patients between the ages of 18 and 80 with eosinophilic esophagitis diagnosed by a combination of compatible symptoms, endoscopic findings, histology, and lack of response to proton pump inhibitors or negative pH study, and are now in histologic remission( <15phf) by the use of steroids or the six food elimination diet. Volunteers will be selected for not having any history of esophageal symptoms Exclusion Criteria: Vulnerable populations, such as those with diminished mental acuity, will be excluded. Patients taking Nsaids within 48 hours of the d-xylose testing artificial sweeteners within 48 hours of the d-xylose testing History of IBD Currently smoking or history of smoking History of Celiac disease Bacterial overgrowth, motility disorders other diffuse small bowel diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Katzka, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Esophageal Absorption in EoE

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