Completed

Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial

What is being tested

Budesonide plus Prevacid

+ placebo plus Prevacid

Drug

Who is being recruted

Digestive System Diseases+10

+ Eosinophilia

+ Esophageal Diseases

Over 1 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: February 2008

See protocol details

Summary

Principal SponsorRanjan Dohil

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2008

Actual date on which the first participant was enrolled.

This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.

Official TitleUse of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial

NCT00638456

Principal SponsorRanjan Dohil

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 1 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesEosinophiliaEsophageal DiseasesEsophagitisGastroenteritisGastrointestinal DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLeukocyte DisordersEosinophilic Esophagitis

Criteria

3 inclusion criteria required to participate

Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal biopsy

Ages 1 yrs and older

Ability to continue the same diet that the patient was on at the time of EGD with biopsy

10 exclusion criteria prevent from participating

Adverse reaction or allergy to budesonide

Pregnancy

Chronic diseases requiring immunomodulatory therapy

Use of swallowed topical corticosteroids for EE within the past 3 months

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

oral viscous budesonide plus Prevacid

Group II

Placebo

placebo plus Prevacid

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Rady Children's Hospital, San Diego

San Diego, United StatesOpen Rady Children's Hospital, San Diego in Google Maps

CompletedOne Study Center