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Eosinophilic Esophagitis Clinical Therapy Comparison Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01821898
Recruitment Status : Terminated (Recruitment was below expectation)
First Posted : April 1, 2013
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Carla McGuire Davis, Baylor College of Medicine

Tracking Information
First Submitted Date  ICMJE March 27, 2013
First Posted Date  ICMJE April 1, 2013
Last Update Posted Date November 29, 2019
Actual Study Start Date  ICMJE July 9, 2013
Actual Primary Completion Date September 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 29, 2013)
EoE Score [ Time Frame: 8 weeks ]
Primary outcome will be the EoE endoscopy score (eosinophil/high powered field) on repeat biopsy after the treatment phase.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
  • Quality of Life Survey Score [ 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2013)
  • Quality of Life [ Time Frame: 8 weeks ]
    PedsQL to assess overall quality of life.
  • Symptom score [ Time Frame: 8 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 Proteomic and immune analysis [ Time Frame: 8 weeks ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Eosinophilic Esophagitis Clinical Therapy Comparison Trial
Official Title  ICMJE Eosinophilic Esophagitis Clinical Therapy Comparison Trial
Brief Summary

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."

Detailed Description

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 40 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Eosinophilic Esophagitis
Intervention  ICMJE
  • 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
  • Other: Elimination diet
    This group will receive an elimination diet
Study Arms  ICMJE
  • Active Comparator: Positive for food allergy: Group A
    Oral Budesonide
    Intervention: Drug: Oral Budesonide
  • Active Comparator: Positive for food allergy: Group B
    Elimination diet
    Intervention: Other: Elimination diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 26, 2019)
5
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2013)
120
Actual Study Completion Date  ICMJE September 24, 2018
Actual Primary Completion Date September 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Signed written informed consent and assent if applicable prior to performing any study specific procedure.
  2. Male or female subjects aged 3-17 years old.
  3. Diagnosis of EoE within 2 months of enrollment (greater than or equal to 15 eosinophils per high powered field in both proximal or distal esophageal specimens).
  4. Subjects who have failed at least a two month trial of proton pump inhibitor.
  5. A female subject of childbearing potential who is or may become sexually active agrees to routinely use contraception from the time of signing informed consent and assent until 30 days from end of study.
  6. Positive allergy testing on prick and/or patch testing.

Exclusion Criteria

  1. Subjects who are responsive to at least a two month trial of a proton pump inhibitor.
  2. Diagnosis of Inflammatory Bowel Disease or static encephalopathy.
  3. Prior abdominal surgery and other organ disorder not including atopic diseases.
  4. Previous esophageal surgical procedure.
  5. Previous esophageal congenital disorders such as tracheal esophageal fistula and esophageal atresia.
  6. Positive for pregnancy.
  7. Previous therapy within 6 weeks with oral or swallowed steroids or strict dietary elimination of major allergens
  8. Presence of increased eosinophils in the stomach, small intestine, large intestine, and colon based on Debrosse et al.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01821898
Other Study ID Numbers  ICMJE H-27999
36533 ( Other Grant/Funding Number: American Academy of Allergy, Asthama and Immunology )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carla McGuire Davis, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carla M. Davis, MD Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP