FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

CEGIR 7808: Use of Unsedated Transnasal Esophagoscopy (TNE) to Monitor Dietary Management of Eosinophilic Esophagitis in Children

Study Purpose

The purpose of this study is to test the effectiveness of utilizing Transnasal Esophagoscopy as a means of monitoring Eosinophilic Esophagitis patients.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
Interventional
Eligible Ages 8 Years - 22 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

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.

Trial ID:
NCT03342391

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.

Phase
N/A

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Children's Hospital Medical Center, Cincinnati

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Joel Friedlander, M.D.
Principal Investigator Affiliation Children's Hospital Colorado

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherNIHNIHNIHNIH
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Eosinophilic Esophagitis
Study Website: View Trial Website
Additional Details

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.

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.

Children's Hospital Colorado, Denver, Colorado

Status

Recruiting

Address

Children's Hospital Colorado

Denver, Colorado, 80218

Site Contact

Joel Friedlander, M.D.

joel.friedlander@childrenscolorado.org

513-803-3078

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.