Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis

Detailed Description
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This prospective interventional study will investigate the effect of an exclusive, six week elemental diet in adult patients with Eosinophilic Gastroenteritis

Official Title
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Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

Conditions
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Eosinophilic Gastroenteritis

Intervention / Treatment
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* Other: Elemental Diet Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be able to understand and provide informed consent Males and Females ≥18 to 65 years of age; Have diagnosis of EG/EGE Have histologically confirmed active disease > 30 eosinophils/hpf Symptomatic (have experienced symptoms within the last one months prior to enrollment). Female subjects of childbearing potential must have a negative pregnancy test upon study entry 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: Inability or unwillingness of a participant to give written informed consent or comply with study protocol Secondary causes of gastrointestinal and peripheral eosinophilia Eosinophilic infiltration isolated to the esophagus. Pregnancy Immunodeficiency states 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. 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. Have been on an elemental diet previously for six weeks with follow up endoscopy completed. Have participated in any investigative drug study within 6 weeks prior to study entry. Unable to complete study procedures including endoscopy. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment<br>Elemental formula Intervention: Elemental Diet Therapy | Other: Elemental Diet Therapy<br>* Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants in Complete Histologic Remission | Percent of patients who have achieved complete histologic remission. Complete histologic remission is defined as normalization of gastric mucosal eosinophilia (histology with less than the diagnostic threshold levels of mucosal eosinophilia (<30 eosinophils per high power field (HPF)) | 6 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants in Partial Histologic Remission | Percent of participants in partial histologic remission. Partial remission is defined as 50% or more reduction in the maximum of gastric and duodenal peak eosinophil count. | 6 weeks after treatment | 
| Mean Change From Baseline in Maximum Eosinophil Count | The maximum between gastric and duodenal eosinophil counts per high power field were obtained at baseline and 6 weeks. Mean change in count is defined as maximum eosinophil count per high power field (hpf) at 6 weeks minus maximum eosinophil count per hpf at baseline. A reduction (negative change from baseline) in eosinophil count per hpf indicates improvement. Eosinophil counts per hpf from gastric and duodenal biopsies were assessed by research pathologists at 400X magnification. | Baseline, 6 weeks after treatment | 
| Change From Baseline in Total Gastric Endoscopic Reference Score | The gastric endoscopic reference score utilizes standardized criteria for the presence and degree of major endoscopic features. Overall scores range from 0 - 10. Endoscopic features were assessed at baseline and 6 weeks. Change in overall endoscopic reference score is defined as overall score at 6 weeks minus overall score at baseline. A reduction (negative change) in score indicates improvement. | Baseline, 6 weeks after treatment | 
| Change From Baseline in Symptoms of Dyspepsia (SODA) | The SODA questionnaire captures symptoms associated with gastric dyspepsia including symptoms associated with pain and non-pain as well as general satisfaction with present symptoms. The scores range from 0 to 47 for pain; 0 to 35 for non-pain, and 0 to 23 for satisfaction. Higher scores indicate more frequent and/or severe symptoms for pain and non-pain. Higher scores indicate greater satisfaction. Scores were obtained at baseline and 6 weeks. Change in score is defined as total score at 6 weeks minus total score at baseline. A reduction (negative change) indicates improvement in pain and non-pain. An increase (positive change) indicates improvement in satisfaction. | Baseline, 6 weeks after treatment | 
| Change From Baseline in Promis Anxiety | The Promis 29 questionnaire was used to assess anxiety. The range of scores for the anxiety sub-domain is 4 - 20 (raw score) with T-scores ranging from 40 to 82. A higher T-score indicates greater anxiety. Scores were obtained at baseline and 6 weeks. Change in score is defined as total score at 6 weeks minus total score at baseline. | Baseline, 6 weeks after treatment |