Esophageal Absorption in EoE

NCT02314455 | Terminated

• 1 other identifier: 13-009092
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Eosinophilic Esophagitis

Keywords

Eosinophilic Esophagitis; EoE; dysphagia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• D-xylose testing compared to endoscopy/biopsy findings.

  1 year

Study Arms (1)

D-xylose, water, honey

EXPERIMENTAL

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

Other: D-xylose

Interventions

D-xylose 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.

Also known as: Eosinophilic esophagitis, Absorption study

D-xylose, water, honey

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis; Deglutition Disorders

Interventions

Xylose

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pentoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• David Katzka, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: December 11, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 21, 2016

Record last verified: 2016-07

Locations

US (1)