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Esophageal Absorption in EoE (EoE)

This study has been terminated.
(Early analysis showed negative results. It was decided to halt the study.)
Sponsor:
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02314455
First received: November 10, 2014
Last updated: July 19, 2016
Last verified: July 2016
  Purpose
To determine how the esophagus in active and inactive stages of eosinophilic esophagitis tranmit fluids.

Condition Intervention
Eosinophilic Esophagitis
Other: D-xylose

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Esophageal Absorption in Eosinophilic Esophagitis

Resource links provided by NLM:


Further study details as provided by David A. Katzka, Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 14
Study Start Date: September 2014
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02314455

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: David Katzka, MD Mayo Clinic
  More Information

Responsible Party: David A. Katzka, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02314455     History of Changes
Other Study ID Numbers: 13-009092
Study First Received: November 10, 2014
Last Updated: July 19, 2016

Keywords provided by David A. Katzka, Mayo Clinic:
Eosinophilic Esophagitis
EoE
dysphagia

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 25, 2017