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
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis||Other: D-xylose||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Esophageal Absorption in Eosinophilic Esophagitis|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
Experimental: D-xylose, water, honey
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314455
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||David Katzka, MD||Mayo Clinic|