Eosinophilic Esophagitis Clinical Therapy Comparison Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01821898
• Date of registration: 27/03/2013
• Prospective Registration: Yes
• Primary sponsor: Baylor College of Medicine
• Public title: Eosinophilic Esophagitis Clinical Therapy Comparison Trial
• Scientific title: Eosinophilic Esophagitis Clinical Therapy Comparison Trial
• Date of first enrolment: July 9, 2013
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01821898
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Carla M. Davis, MD
• Affiliation: Baylor College of Medicine

Key inclusion & exclusion 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.



Age minimum: 3 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Other: Elimination diet

Drug: Oral Budesonide

Primary Outcome(s)

EoE Score [Time Frame: 16 weeks]

Secondary Outcome(s)

Exploratory studies [Time Frame: Conclusion of study]

Quality of Life Survey Score [Time Frame: 16 weeks]

Symptom score [Time Frame: 16 weeks]

Secondary ID(s)

36533

H-27999

Source(s) of Monetary Support

Please refer to primary and secondary sponsors