EoE RCT Fluticasone & Omeprazole vs Fluticasone Alone

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of combination therapy with omeprazole and swallowed fluticasone vs fluticasone therapy and placebo in the treatment of Eosinophilic Esophagitis (EoE) in children and adults. This study will be a double-blinded, randomized controlled trial. The primary outcome measured will be histologic assessment of esophageal tissue biopsies measuring number of eosinophils per high power field (eos/hpf). Secondary outcomes will be endoscopic findings and symptomatic changes following therapy using validated endoscopic scoring measures and participant surveys, respectively.

Clinical Trial Description

Subjects that meet study inclusion criteria will be recruited from the Adult and Pediatric Gastroenterology clinics at Walter Reed National Military Medical Center through routine clinic visits, will meet with an investigator, and complete informed consent/assent. The participants will then complete a validated clinical symptom reporting tool - the Eosinophilic Esophagitis symptom activity index (EEsAI) for age 18 and above, or the Pediatric Quality of Life Inventory (PedsQL) for age 6-17yrs - and have their initial Esophagogastroduodenoscopy (EGD) images evaluated via a validated Endoscopic Reference Score (EREFS). Esophageal biopsies taken at the patient's initial EGD will be assessed by 2 designated blinded pathologists to record the number of eosinophils per high power field (HPF), as well as perform tissue immunohistochemical staining for eotaxin-3. Participants will be block randomized to treatment or control groups and complete 8 weeks of therapy, with a phone follow up at 4 weeks for medication compliance. At the completion of 8 weeks of therapy, the participants will have repeat EGD to assess for mucosal healing, which is the standard of care in the treatment of EoE. At this EGD, the images will be assigned an EREFS and the biopsies will be evaluated for eosinophils per high powered field and eotaxin-3 staining. The patient will also complete an EEsAI or PedsQL. This procedure will end the 8 week study period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03781596
Study type	Interventional
Source	Walter Reed National Military Medical Center
Contact	Steve B Min, M.D.
Phone	301-295-4959
Email	steve.b.min.mil@mail.mil
Status	Recruiting
Phase	Phase 4
Start date	October 2, 2018
Completion date	October 2, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03382678` - CEGIR 7807: Validation of Online Cohort of EGID Patients Enrolled in RDCRN CEGIR Contact Registry
Completed	`NCT05083312` - Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial	Phase 3
Completed	`NCT04593251` - Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis	Phase 1
Completed	`NCT03633617` - Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)	Phase 3
Recruiting	`NCT04941742` - The Use of Fractionated Exhaled Nitric Oxide in the Diagnosis and Assessment of Disease Activity of Eosinophilic Esophagitis (Validation Phase)
Terminated	`NCT04543409` - A Study of Benralizumab in Patients With Eosinophilic Esophagitis	Phase 3
Terminated	`NCT02314455` - Esophageal Absorption in EoE	N/A
Completed	`NCT01953575` - Mucosal Impedance and Eosinophilic Esophagitis	N/A
Completed	`NCT01386112` - Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis	Phase 1/Phase 2
Recruiting	`NCT04991935` - Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis	Phase 3
Not yet recruiting	`NCT05896891` - San Raffaele EoE Biobank
Active, not recruiting	`NCT05482256` - A Study of Detergents in the Pathogenesis of Eosinophilic Esophagitis	N/A
Recruiting	`NCT04149470` - Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)	Phase 4
Recruiting	`NCT04416217` - Eosinophilic Esophagitis Steroid Safety Study
Completed	`NCT05084963` - A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis	Phase 2
Completed	`NCT02579876` - Milk Patch for Eosinophilic Esophagitis	Phase 2
Recruiting	`NCT02331849` - Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry.	N/A
Active, not recruiting	`NCT02202590` - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus	N/A
Active, not recruiting	`NCT05176249` - Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population
Completed	`NCT00961233` - Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms