Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 70 Years|
Inclusion Criteria:- 10 patients with diagnosed EoE (greater than 20 eosinophils per HPF) on esophageal biopsy will be included as the diseased population - 7 controls (subjects without GI symptoms and known GI disease)
Exclusion Criteria:- bleeding diathesis or contraindication to esophageal biopsies - severe sleep apnea - incarceration - pregnancy - inability to lie flat for 2 hours - history of bleeding disorder - Use of steroids - Breast feeding - Allergy to heparin or history of severe reaction to heparin - allergy to mucomyst or severe asthma
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Early Phase 1|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Utah|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Gerald Gleich, MD|
|Principal Investigator Affiliation||University of Utah|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Experimental: Healthy Controls
7 controls (subjects without GI symptoms and known GI disease), subjects will receive the radiopharmaceutical agent orally
Experimental: Eosinophilic Esophagitis Patients
10 patients with diagnosed EoE (greater than 15 eosinophils per HPF) on esophageal biopsy will be included as the diseased population, subjects will receive the radiopharmaceutical agent orally
Radiation: - Computerized Tomography scan
imaging scan from a person's eyes to their thighs
Radiation: - Single Photon Emission Computed Tomography scans
imaging scan taken during, and after, the administration of the radioactive agent
Drug: - Technetium Tc 99M
subjects are administered radioactive heparin as part of study participation.
Radiation: - Planar Images
2 dimensional imaging - whole body planar scans
Procedure: - Esophagogastroduodenoscopy
esophagogastroduodenoscopy with tissue biopsies
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.