Clinical trial NCT01821898: Eosinophilic Esophagitis Clinical Therapy Comparison Trial
Official title: Eosinophilic Esophagitis Clinical Therapy Comparison Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophil
Reflux
Esophagus
Food allergy
Trouble Swallowing
Pediatrics
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2013-04-01
Enrollment: 3
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Peak Number of Eosinophils/High Powered Field
timeFrame: 16 weeks
Secondary outcomes:
measure: Quality of Life Survey Score
timeFrame: 16 weeks
measure: Symptom Score
timeFrame: 16 weeks
measure: Exploratory Studies
timeFrame: Conclusion of study
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Carla M. Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: