Esophageal Absorption in EoE

Not Applicable

Terminated

• Conditions: Eosinophilic Esophagitis
• Interventions: Other: D-xylose

• Registration Number: NCT02314455
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-12-08
• Study First Posted: 2014-12-11
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
D-xylose, water, honey	D-xylose	* 25 grams of D-xylose * 10 cc of water * 2 teaspoons of honey

Primary Outcome Measures

Name	Time	Method
Reliability of the d-xylose testing defined by the serum levels	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.

Secondary Outcome Measures

Name	Time	Method
D-xylose testing compared to endoscopy/biopsy findings.	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States