Eosinophilic Esophagitis Clinical Therapy Comparison Trial

• Status: Terminated
• Trial end date: 2018-09-24
• Target enrollment: 0
• Participant gender: All

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."

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Budesonide

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.