CEGIR 7809: Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

This prospective interventional study will investigate the effect of a six week elemental
diet in adult patients with Eosinophilic Gastroenteritis

Inclusion Criteria:

1. Participant must be able to understand and provide informed consent

2. Males and Females ≥18 to 65 years of age;

3. Have diagnosis of EG/EGE

4. Have histologically confirmed active disease > 30 eosinophils/hpf

5. Symptomatic (have experienced symptoms within the last one months prior to
enrollment).

6. Female subjects of childbearing potential must have a negative pregnancy test upon
study entry

7. Female (and male) subjects with reproductive potential, must agree to use FDA approved
methods of birth control for the duration of the study-specific methods may be listed,
if applicable

Exclusion Criteria:

1. Inability or unwillingness of a participant to give written informed consent or comply
with study protocol

2. Secondary causes of gastrointestinal and peripheral eosinophilia

3. Eosinophilic infiltration isolated to the esophagus.

4. Pregnancy

5. Immunodeficiency states

6. Have been treated with topical swallowed steroids within the last 6 weeks or systemic
steroids within the last 2 months unless repeat endoscopy is performed and shows
active inflammation on these therapies in which case these medications will be allowed
to be continued without dose escalation.

7. Have taken immunosuppression medication or immunomodulators within 2 months of the
study unless the recent/baseline endoscopy has active histologic inflammation while on
these medications. In this case, these medications will be permitted to be continued
as long as the dose is not escalated during the treatment phase.

8. Have been on an elemental diet previously for six weeks with follow up endoscopy
completed.

9. Have participated in any investigative drug study within 6 weeks prior to study entry.

10. Unable to complete study procedures including endoscopy.

11. Past or current medical problems or findings from physical examination or laboratory
testing that are not listed above, which, in the opinion of the investigator, may pose
additional risks from participation in the study, may interfere with the participant's
ability to comply with study requirements or that may impact the quality or
interpretation of the data obtained from the study.