NCT01821898

Eosinophilic Esophagitis Clinical Therapy Comparison Trial

Terminated Phase 2 Results posted Last updated 11 January 2021

What this trial tests

Phase 2 trial testing Oral Budesonide in Eosinophilic Esophagitis in 3 participants. Terminated before completion.

Timeline

9 July 2013

Primary endpoint
24 September 2018

24 September 2018

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	9 July 2013
Primary completion	24 September 2018
Estimated completion	24 September 2018
Sites	1 location across United States

Drugs / interventions tested

• Oral Budesonide
• Elimination diet

Conditions studied

• Eosinophilic Esophagitis — all drugs for Eosinophilic Esophagitis →

Sponsor

Baylor College of Medicine

Who can join

Adults 3 to 17, any sex, with Eosinophilic Esophagitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Eosinophilic Esophagitis (EoE) is a disorder in which a type of white blood cell (eosinophil) involved in allergic reactions, enter and cover the walls of the esophagus (food pipe). As a result, the esophagus becomes swollen and blocked making it difficult to swallow, and this leads to heartburn. In severe cases it can lead to food getting stuck in the esophagus and poor growth or weight loss in children

The main purpose of this research study is to compare the effectiveness of two different types of treatment for EoE:

1. Oral viscous budesonide- which is a steroid medication that has been used to treat asthma. Recently, it has been used as a therapy to treat the eosinophilic inflammation in EoE, and
2. Specific food elimination.

The study will also be looking to see if a blood test is useful in following the progression of EoE. Currently the only way to follow EoE is by repeating endoscopy, which is a more "invasive test."

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Medical treatment of eosinophilic esophagitis.
   Franciosi JP, Gordon M, Sinopoulou V, Dellon ES, et al · · 2023 · cited 25× · PMID 37470293 · DOI 10.1002/14651858.cd004065.pub4
2. Systematic review of outcome measures in pediatric eosinophilic esophagitis treatment trials.
   Rubin T, Clayton J, Adams D, Persad R, et al · · 2016 · cited 5× · PMID 27582776 · DOI 10.1186/s13223-016-0144-y
3. The Therapeutic Pipeline for Eosinophilic Esophagitis: Current Landscape and Future Directions.
   Pasta A, Bertin L, Mari A, Calabrese F, et al · · 2025 · cited 1× · PMID 41471371 · DOI 10.3390/ph18121882