Eosinophilic Esophagitis Clinical Therapy Comparison Trial

Eosinophilic Esophagitis Clinical Trial

Official title:

Eosinophilic Esophagitis Clinical Therapy Comparison Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01821898
• Other study ID #: H-27999
• Secondary ID: 36533
• Status: Terminated
• Phase: Phase 2
• Start date: July 9, 2013
• Est. completion date: September 24, 2018

Study information

• Verified date: December 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 24, 2018
• Est. primary completion date: September 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

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:
• Elimination diet
This group will receive an elimination diet

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Number of Eosinophils/High Powered Field	The primary outcome will be the peak eosinophil/high powered field on repeat biopsy after the treatment phase.	16 weeks
Secondary	Quality of Life Survey Score	PedsQL total survey score to assess overall quality of life before and after treatment	16 weeks
Secondary	Symptom Score	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.	16 weeks
Secondary	Exploratory Studies	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.	Conclusion of study