Eosinophilic Esophagitis Clinical Therapy Comparison Trial

NCT ID: NCT01821898

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-09
• Study Completion Date: 2018-09-24

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).

Conditions

Eosinophilic Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Positive for food allergy: Group A

Oral Budesonide

Group Type: ACTIVE_COMPARATOR

Oral Budesonide

Intervention Type: DRUG

This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day

Positive for food allergy: Group B

Elimination diet

Group Type: ACTIVE_COMPARATOR

Elimination diet

Intervention Type: OTHER

This group will receive an elimination diet

Interventions

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

Intervention Type: DRUG

Elimination diet

This group will receive an elimination diet

Intervention Type: OTHER

Other Intervention Names

Steroid

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Carla McGuire Davis

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carla M. Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Children's Hospital

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

36533

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-27999

Identifier Type: -

Identifier Source: org_study_id