Esophageal Absorption in EoE

NCT ID: NCT02314455

Last Updated: 2016-07-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-07-31

Brief Summary

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

Conditions

Eosinophilic Esophagitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

D-xylose, water, honey

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

Group Type: EXPERIMENTAL

D-xylose

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Eosinophilic esophagitis; Absorption study

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

David A. Katzka

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Katzka, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

13-009092

Identifier Type: -

Identifier Source: org_study_id