Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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8 August 2016 |
Main ID: |
NCT02314455 |
Date of registration:
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10/11/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Esophageal Absorption in EoE
EoE |
Scientific title:
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Esophageal Absorption in Eosinophilic Esophagitis |
Date of first enrolment:
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September 2014 |
Target sample size:
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14 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT02314455 |
Study type:
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Interventional |
Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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David Katzka, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Eosinophilic Esophagitis
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Intervention(s)
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Other: D-xylose
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Primary Outcome(s)
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Reliability of the d-xylose testing defined by the serum levels
[Time Frame: 1 year]
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Secondary Outcome(s)
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D-xylose testing compared to endoscopy/biopsy findings.
[Time Frame: 1 year]
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Secondary ID(s)
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13-009092
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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