Esophageal Absorption in EoE (EoE)

July 19, 2016 updated by: David A. Katzka, Mayo Clinic

Esophageal Absorption in Eosinophilic Esophagitis

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D-xylose, water, honey
  • 25 grams of D-xylose
  • 10 cc of water
  • 2 teaspoons of honey
Other: D-xylose
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.
Other Names:
  • Eosinophilic esophagitis
  • Absorption study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reliability of the d-xylose testing defined by the serum levels
Time Frame: 1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
D-xylose testing compared to endoscopy/biopsy findings.
Time Frame: 1 year
Histologic parameters will include grading of spongiosis as an indicator of dilated intercellular spaces which will be correlated to serum levels of D-xylose.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: David Katzka, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 11, 2014

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-009092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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