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Eosinophilic Esophagitis Clinical Therapy Comparison Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Baylor College of Medicine
Sponsor:
Information provided by (Responsible Party):
Carla McGuire Davis, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01821898
First received: March 27, 2013
Last updated: August 1, 2016
Last verified: August 2016
  Purpose

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."


Condition Intervention Phase
Eosinophilic Esophagitis
Drug: Oral Budesonide
Other: Elimination diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Eosinophilic Esophagitis Clinical Therapy Comparison Trial

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Positive for food allergy: Group A
Oral Budesonide
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
Elimination diet
Other: Elimination diet
This group will receive an elimination diet

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 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).

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821898

Contacts
Contact: Carla M Davis, MD 832-824-1319 CMDavis@texaschildrens.org
Contact: Daisy Tran, RN 832-824-3398 dxtran1@texaschildrens.org

Locations
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         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Carla M. Davis, MD Baylor College of Medicine
  More Information

Responsible Party: Carla McGuire Davis, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01821898     History of Changes
Other Study ID Numbers: H-27999
36533 ( Other Grant/Funding Number: American Academy of Allergy, Asthama and Immunology )
Study First Received: March 27, 2013
Last Updated: August 1, 2016

Keywords provided by Baylor College of Medicine:
Eosinophil
Reflux
Esophagus
Food allergy
Trouble Swallowing
Pediatrics

Additional relevant MeSH terms:
Esophagitis
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 25, 2017