Eosinophilic Esophagitis Clinical Therapy Comparison Trial
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|ClinicalTrials.gov Identifier: NCT01821898|
Recruitment Status : Recruiting
First Posted : April 1, 2013
Last Update Posted : August 2, 2016
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:
- 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
- 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."
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Esophagitis||Drug: Oral Budesonide Other: Elimination diet||Phase 2|
This study is a open label, randomized, prospective clinical trial comparing the efficacy of a topical steroid preparation to an antigen (food) elimination diet.
A total of 60 participants will be recruited for this study that are positive for food allergens. Study participants will be randomly assigned to treatments as described below, and the duration of each treatment phase will be 16 weeks.
The subjects will be randomized to group A and B. Subject and study team will NOT be blinded to the group assignments.
Group A will receive oral viscous budesonide at a dose of 1 or 2 mg daily depending on the height.
Group B will receive an elimination diet (elimination of the foods the subject is allergic to).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Eosinophilic Esophagitis Clinical Therapy Comparison Trial|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2018|
Active Comparator: Positive for food allergy: Group A
Drug: Oral Budesonide
This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day
Other Name: Steroid
Active Comparator: Positive for food allergy: Group B
Other: Elimination diet
This group will receive an elimination diet
- EoE Score [ Time Frame: 16 weeks ]Primary outcome will be the EoE endoscopy score (eosinophil/high powered field) on repeat biopsy after the treatment phase.
- Quality of Life [ Time Frame: 16 weeks ]PedsQL to assess overall quality of life.
- Symptom score [ Time Frame: 16 weeks ]Assess the subject's symptoms using the validated tool termed Pediatric Eosinophilic Esophagitis (EoE) Symptom Severity Module by measuring % of normal bolus transit swallow and % of normal peristaltic esophageal body contractions.
- Exploratory studies [ Time Frame: Conclusion of study ]Proteomic studies search for certain proteins in the blood that may be linked to active EoE. Immune analysis will help identify better methods for diagnosis, treatment, and prevention of immune system changes leading to diseases.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01821898
|Contact: Carla M Davis, MD||832-824-1319||CMDavis@texaschildrens.org|
|Contact: Daisy Tran, RNfirstname.lastname@example.org|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Carla M Davis 832-824-1319 CMDavis@texaschildrens.org|
|Principal Investigator: Carla M. Davis, MD|
|Sub-Investigator: Anthony P. Olive, MD|
|Principal Investigator:||Carla M. Davis, MD||Baylor College of Medicine|