FARE Clinical Trial Finder
CEGIR 7808: Use of Unsedated Transnasal Esophagoscopy (TNE) to Monitor Dietary Management of Eosinophilic Esophagitis in Children
The purpose of this study is to test the effectiveness of utilizing Transnasal Esophagoscopy as a means of monitoring Eosinophilic Esophagitis patients.
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.
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|Eligible Ages||8 Years - 22 Years|
Inclusion Criteria:1. Participant must be able to understand and provide informed consent/assent 2. Males and females ages 8-22 years of age 3. History of an established diagnosis of EoE 4. Recent EGD or TNE (with in past 1 year) showing EoE remission (e.g. <15 x eosinophils/hpf) and currently without significant symptoms attributed to EoE. 5. On a four food or less elimination diet not including or counting foods restricted at time of EoE diagnosis 6. Female subjects of childbearing potential must have a negative pregnancy test upon study entry 7. Female subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study 8. Children and families have desire to reintroduce potential food allergens and the food antigen has been recommended with plans for its introduction as part of Standard of Care by the child's allergist and/or gastroenterologist 9. Children and families willing to undergo unsedated serial TNE
Exclusion Criteria:1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol 2. Bleeding disorder 3. Unwilling to undergo unsedated TNE 4. Unwilling or unable to come to hospital at least 3 times over 6 weeks. 5. Currently treated with swallowed corticosteroids 6. Treated with oral corticosteroids within 8 weeks of the start of the study. 7. EoE has been symptomatic with clinically significant symptoms attributable to EoE including dysphagia, abdominal pain or vomiting in the period since endoscopy 8. The finding of uncontrolled cough, significant rhinorrhea or rhinitis obstructing nasal passages, oxygen saturations <92% (high altitude normal saturation), temperature >38 degrees Celsius, significant gastrointestinal illness within 1 week of TNE, or provider determination of significant illness during pre-procedure history and physical on the day that the TNE is planned. 9. Pregnancy, breast feeding or plans to become pregnant 10. Unable to complete study procedures including endoscopy. 11. Allergy to any material or medicine used for procedures 12. Use of investigational drugs within 16 weeks of participation 13. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Children's Hospital Medical Center, Cincinnati|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Joel Friedlander, M.D.|
|Principal Investigator Affiliation||Children's Hospital Colorado|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
A participant with an established diagnosis of EoE who is undergoing Standard of Care treatment with a four or less food elimination diet (not including or counting foods restricted at time of EoE diagnosis) without swallowed steroid medication (to optimize statistical chance of finding a trigger food for EoE), is in histological remission, and has been recommended as part of Standard of Care to start a single new food introduction by the subject's clinical allergist or gastroenterologist will be enrolled in the study. 14-17 days after the introduction of the clinically recommended single food antigen, a TNE will be performed to assess the esophageal mucosa. TNE will be performed every 2 weeks for six weeks (3 total TNE) to evaluate recurrence time of mucosal eosinophilia (>15 eos/HPF), other histological changes, and patient tolerance to serial TNE. At week 6 a sedated esophagoscopy will be offered as an alternative choice to TNE if the participant chooses.
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