Esophageal Absorption in EoE

Eosinophilic Esophagitis Clinical Trial

— EoE  

Official title:

Esophageal Absorption in Eosinophilic Esophagitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02314455
• Other study ID #: 13-009092
• Status: Terminated
• Phase: N/A
• First received: November 10, 2014
• Last updated: July 19, 2016
• Start date: September 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No
Secondary	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.	1 year	No