Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis

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

Study Overview

• Status: Completed
• Conditions: Eosinophilic Gastroenteritis
• Intervention / Treatment: Other: Elemental Diet Therapy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60208
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Center for Advancing Translational Sciences (NCATS); Office of Rare Diseases (ORD)
• Investigators: Principal Investigator: Nirmala Gonsalves, M.D., Northwestern University

Publications and helpful links

Helpful Links

• Related info

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Actual): September 5, 2019
• Study Completion (Actual): October 5, 2019

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Hypersensitivity; Esophageal Diseases; Esophagitis; Leukocyte Disorders; Gastritis; Gastroenteritis; Eosinophilic Esophagitis; Enteritis; Eosinophilia
• Other Study ID Numbers: 2017-2766; U54AI117804 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No