Completed

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

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What is being tested

Budesonide plus Prevacid

+ placebo plus Prevacid
Drug
Who is being recruted

Digestive System Diseases
+9

+ Eosinophilia
+ Esophageal Diseases
Over 1 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2
Interventional
Study Start: February 2008
See protocol details

Summary

Principal SponsorRanjan Dohil
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2008Actual 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 18, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 1 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Digestive System Diseases
Eosinophilia
Esophageal Diseases
Esophagitis
Gastroenteritis
Gastrointestinal Diseases
Hematologic Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Leukocyte Disorders
Eosinophilic Esophagitis
Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Adverse reaction or allergy to budesonide * Pregnancy * Chronic diseases requiring immunomodulatory therapy * Use of swallowed topical corticosteroids for EE within the past 3 months * Use of systemic steroids 2 months prior to study entry * Upper gastrointestinal bleed within 4 months of study entry * Chronic use of medications that predispose to upper gastrointestinal bleeding including non-steroidal anti-inflammatory medications or anticoagulants * Evidence of adrenal suppression prior to study entry * Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis * Recent changes in asthma or allergic rhinitis therapy for 3 months

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

Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
Group II
Placebo
placebo plus Prevacid

Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
Study Objectives
Primary Objectives

Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.
Secondary Objectives

Endoscopy scoring tool took into account the following categories: Mucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/"tissue-paper" mucosa Histology scoring tools Epithelial histology score Peak eosinophil count Each category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease.

Total score was based on the following symptoms: Heartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding Each symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms.

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 DiegoSan Diego, United StatesSee the location
CompletedOne Study Center
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