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Esophageal Absorption in EoE (EoE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02314455
Recruitment Status : Terminated (Early analysis showed negative results. It was decided to halt the study.)
First Posted : December 11, 2014
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
David A. Katzka, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE November 10, 2014
First Posted Date  ICMJE December 11, 2014
Last Update Posted Date July 21, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Esophageal Absorption in EoE
Official Title  ICMJE Esophageal Absorption in Eosinophilic Esophagitis
Brief Summary To determine how the esophagus in active and inactive stages of eosinophilic esophagitis tranmit fluids.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Eosinophilic Esophagitis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: D-xylose, water, honey
  • 25 grams of D-xylose
  • 10 cc of water
  • 2 teaspoons of honey
Intervention: Other: D-xylose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 19, 2016)
14
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2014)
40
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02314455
Other Study ID Numbers  ICMJE 13-009092
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David A. Katzka, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Katzka, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP