Back to resultsEffect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
Primary Purpose
Eosinophilic Gastroenteritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Elemental Diet Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Eosinophilic Gastroenteritis
Eligibility Criteria
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.
Sites / Locations
- Northwestern University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment
Arm Description
Elemental formula Intervention: Elemental Diet Therapy
Outcomes
Primary Outcome Measures
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))
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03320369
First Posted
October 12, 2017
Last Updated
October 5, 2020
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), Office of Rare Diseases (ORD), National Center for Advancing Translational Sciences (NCATS)
1. Study Identification
Unique Protocol Identification Number
NCT03320369
Brief Title
Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
Official Title
Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
October 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the 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), Office of Rare Diseases (ORD), National Center for Advancing Translational Sciences (NCATS)
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis
Detailed Description
This prospective interventional study will investigate the effect of an exclusive, six week elemental diet in adult patients with Eosinophilic Gastroenteritis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Gastroenteritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Other
Arm Description
Elemental formula Intervention: Elemental Diet Therapy
Intervention Type
Other
Intervention Name(s)
Elemental Diet Therapy
Intervention Description
Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete
Primary Outcome Measure Information:
Title
Percent of Participants in Complete Histologic Remission
Description
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))
Time Frame
6 weeks after treatment
Secondary Outcome Measure Information:
Title
Percent of Participants in Partial Histologic Remission
Description
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.
Time Frame
6 weeks after treatment
Title
Mean Change From Baseline in Maximum Eosinophil Count
Description
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.
Time Frame
Baseline, 6 weeks after treatment
Title
Change From Baseline in Total Gastric Endoscopic Reference Score
Description
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.
Time Frame
Baseline, 6 weeks after treatment
Title
Change From Baseline in Symptoms of Dyspepsia (SODA)
Description
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.
Time Frame
Baseline, 6 weeks after treatment
Title
Change From Baseline in Promis Anxiety
Description
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.
Time Frame
Baseline, 6 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nirmala Gonsalves, M.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.rarediseasesnetwork.org/cms/CEGIR
Description
Related info
Learn more about this trial
Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
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