Non-endoscopic Tracking of Disease Activity in Eosinophilic Esophagitis
A legfontosabb adatok
- Ki végzi
- University of Colorado, Denver
- Azonosító
- Állapot
- Visszavonva
- Kezdés
- 2021. jún. 1.
- Befejezés
- 2023. dec. 1.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- Four Food Elimination Diet
- A regiszteradat frissítve
- 2023. március 31.
- Miért állt le
- Study grant not obtained; not moving forward with study at this time.
Ki vehet részt
- Életkor
- 7 év – 65 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 15 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
A vizsgálatról
Mit akar kideríteni a vizsgálat
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).
A vizsgálat csoportja
- Four Food Elimination Diet (FFED)A vizsgált kezelés
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.
Kezelés: Four Food Elimination Diet
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Non-endoscopic Tracking of Disease Activity During Dietary Interventions in Eosinophilic Esophagitis
- A regiszteradat frissítve
- 2023. március 31.