Non-endoscopic Tracking of Disease Activity in Eosinophilic Esophagitis
Key facts
- Who runs it
- University of Colorado, Denver
- Trial code
- Status
- Withdrawn
- Started
- 1 Jun 2021
- Ended
- 1 Dec 2023
- Type of study
- Interventional
- Treatments tested
- Four Food Elimination Diet
- Record updated
- 31 March 2023
- Why it stopped
- Study grant not obtained; not moving forward with study at this time.
Who can take part
- Age
- 7 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Participant must be able to understand and provide informed consent
- Males and Females ≥7 years of age to 65 years of age
- Have diagnosis of EoE
- Have histologically confirmed active disease ≥15 eosinophils/hpf
- Symptomatic (have experienced symptoms within the last one months prior to enrollment)
- Female subjects of childbearing potential must have a negative pregnancy test upon study entry
- Female (and male) subjects with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study
Who cannot take part
- Have participated in any investigative drug study within 6 weeks prior to study entry
- 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
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- Secondary causes of eosinophilia
- Pregnancy
- Immunodeficiency states
- Unable to complete study procedures including endoscopy
- Luminal stricture identified <13mm which would prevent passage of the EST and prevent assessment of mucosal inflammation
About the trial
What the trial wants to find out
To prospectively determine the natural history of inflammation resolution following initiation of diet treatment and to optimize the diet treatment of patients with EoE through the use of a non-endoscopic tracking device, the esophageal string test (EST).
The group in the trial
- Four Food Elimination Diet (FFED)Treatment being tested
There is one arm to the study. All participants meeting eligibility will be assigned to intervention / treatment with a previously defined four food elimination diet (FFED) (Aim 1). This is a longitudinal study in which outcome measures including symptoms, QOL and inflammation at baseline and at 2, 4 and 6 weeks after starting stand of care (SOC) FFED will be measured. Participants meeting eligibility for Aim 2 will have foods added back to the diet using a specified protocol.
Treatment: Four Food Elimination Diet
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Non-endoscopic Tracking of Disease Activity During Dietary Interventions in Eosinophilic Esophagitis
- Record updated
- 31 March 2023