Eosinophilic EsophagitisNCT03342391
CEGIR 7808: Use of Unsedated Transnasal Esophagoscopy (TNE) to Monitor Dietary Management of Eosinophilic Esophagitis in Children
A study testing Transnasal esophagoscopy in people with Eosinophilic Esophagitis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of utilizing Transnasal Esophagoscopy as a means of monitoring Eosinophilic Esophagitis patients. Read more about this study
- Who is it for?
- Ages 5 to 22 years
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- Transnasal esophagoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant must be able to understand and provide informed consent/assent
- Males and females ages 5-22 years of age
- History of an established diagnosis of EoE
- 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.
- On a four food or less elimination diet not including or counting foods restricted at time of EoE diagnosis OR on swallowed topical steroid therapy with any number of foods eliminated from the diet.
- Female subjects of childbearing potential must have a negative pregnancy test upon study entry
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- Female subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study
- Children and families have desire to reintroduce potential food allergens and either 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 OR the swallowed topical steroid therapy has been recommended to be discontinued by the child's allergist and/or gastroenterologist.
- Children and families willing to undergo unsedated serial TNE
Who cannot join
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Bleeding disorder
- Unwilling to undergo unsedated TNE
- Unwilling or unable to come to hospital at least 3 times over 6 weeks.
- Currently treated with a swallowed corticosteroid which is not being discontinued.
- Treated with oral corticosteroids within 8 weeks of the start of the study.
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- More than one change is being made to the EoE treatment regimen (e.g., more than a single food is being reintroduced during the study period; the swallowed topical steroid is being discontinued at the same time a food is being introduced).
- EoE has been symptomatic with clinically significant symptoms attributable to EoE including dysphagia, abdominal pain or vomiting in the period since endoscopy
- 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.
- Pregnancy, breast feeding or plans to become pregnant
- Unable to complete study procedures including endoscopy.
- Allergy to any material or medicine used for procedures
- Use of investigational drugs within 16 weeks of participation
- 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 locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Denver, Colorado, 80218
About this study
The purpose of this study is to test the effectiveness of utilizing Transnasal Esophagoscopy as a means of monitoring Eosinophilic Esophagitis patients.
Read the detailed description
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) OR is on topical swallowed steroid therapy with any number of foods eliminated from the diet, is in histological remission, and has been recommended as part of Standard of Care to start a single new food introduction OR remove the swallowed steroid treatment 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.
- Conditions
- Eosinophilic Esophagitis
- Being tested
- Transnasal esophagoscopy
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal esophagoscopyOther
single food antigen introduction OR removal of topical swallowed steroid therapy followed by surveillance utilizing TNE
| Study group | Role | What they receive |
|---|---|---|
| Treatment Phase | Other | Treatment Phase will evaluate the effectiveness of Transnasal Esophagoscopy (TNE) as an acceptable form of monitoring Eosinophilic Esophagitis Receives: Other: Transnasal esophagoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological Improvement
To prospectively and serially evaluate the recurrence of esophageal eosinophilia (>15 eosinophils per high power field) after a clinical single food antigen introduction OR removal of swallowed topical steroid therapy by the subject's clinical allergist or gastroenterologist in children with EoE using unsedated Transnasal Endoscopy/Esophagoscopy.
Measured: 6 weeks
Secondary outcomes (3)
Endoscopic Appearances/Histological Findings
- To identify serially the clinical (endoscopic appearances) and other histological findings (lamina propria fibrosis, mast cells, lymphocytes) associated with dietary food introductions OR swallowed topical steroid therapy removal in children with EoE.
Measured: 6 weeks
Sample Size
- To determine and evaluate mucosal sample size obtained during TNE (2.0 mm or 1.2 mm forceps) compared to that obtained during those same subjects' previous traditional sedated endoscopy/esophagoscopy (2.8 mm forceps).
Measured: 6 weeks
Decision to participate
- To assess family factors determining decision to complete TNE study and subject's satisfaction with serial TNE using the previously reported TNE Qualitative Questionnaire, the General Anxiety Disorder (GAD)-7 Anxiety Instrument and a structured interview.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Oct 2017
- Primary completion31 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Rare Diseases (ORD), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Joel Friedlander, M.D., Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342391
- Sponsor's protocol ID
- 2017-0237
- Status last verified
- Mar 2021
- First submitted
- 9 Nov 2017
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CEGIR 7808: Use of Unsedated Transnasal Esophagoscopy (TNE) to Monitor Dietary Management of Eosinophilic Esophagitis in Children
- ClinicalTrials.gov ID
- NCT03342391
- Acronym / sponsor ID
- 2017-0237
- Conditions
- Eosinophilic Esophagitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Rare Diseases (ORD), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effectiveness of utilizing Transnasal Esophagoscopy as a means of monitoring Eosinophilic Esophagitis patients.
Detailed description
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) OR is on topical swallowed steroid therapy with any number of foods eliminated from the diet, is in histological remission, and has been recommended as part of Standard of Care to start a single new food introduction OR remove the swallowed steroid treatment 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Phase | Other | Other: Transnasal esophagoscopyTreatment Phase will evaluate the effectiveness of Transnasal Esophagoscopy (TNE) as an acceptable form of monitoring Eosinophilic Esophagitis |
Who may qualify
- Ages
- 5 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Participant must be able to understand and provide informed consent/assent
- Males and females ages 5-22 years of age
- History of an established diagnosis of EoE
- 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.
- On a four food or less elimination diet not including or counting foods restricted at time of EoE diagnosis OR on swallowed topical steroid therapy with any number of foods eliminated from the diet.
Key exclusion criteria (14 listed)
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Bleeding disorder
- Unwilling to undergo unsedated TNE
- Unwilling or unable to come to hospital at least 3 times over 6 weeks.
- Currently treated with a swallowed corticosteroid which is not being discontinued.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transnasal esophagoscopysingle food antigen introduction OR removal of topical swallowed steroid therapy followed by surveillance utilizing TNE | Other | Treatment Phase |
Primary outcome
Histological Improvement
Time frame: 6 weeks
To prospectively and serially evaluate the recurrence of esophageal eosinophilia (>15 eosinophils per high power field) after a clinical single food antigen introduction OR removal of swallowed topical steroid therapy by the subject's clinical allergist or gastroenterologist in children with EoE using unsedated Transnasal Endoscopy/Esophagoscopy.
3 secondary outcomes
Endoscopic Appearances/Histological Findings
Time frame: 6 weeks
Sample Size
Time frame: 6 weeks
Decision to participate
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Related infoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Friedlander, M.D. principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transnasal esophagoscopy in people with Eosinophilic Esophagitis, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological Improvement (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.