Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis
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|ClinicalTrials.gov Identifier: NCT03320369|
Recruitment Status : Completed
First Posted : October 25, 2017
Results First Posted : September 28, 2020
Last Update Posted : October 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Eosinophilic Gastroenteritis||Other: Elemental Diet Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Elemental Diet on Adult Patients With Eosinophilic Gastroenteritis|
|Actual Study Start Date :||September 5, 2017|
|Actual Primary Completion Date :||September 5, 2019|
|Actual Study Completion Date :||October 5, 2019|
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
- Percent of Participants in Complete Histologic Remission [ Time Frame: 6 weeks after treatment ]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))
- Percent of Participants in Partial Histologic Remission [ Time Frame: 6 weeks after treatment ]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 [ Time Frame: Baseline, 6 weeks after treatment ]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 [ Time Frame: Baseline, 6 weeks after treatment ]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) [ Time Frame: Baseline, 6 weeks after treatment ]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 [ Time Frame: Baseline, 6 weeks after treatment ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320369
|United States, Illinois|
|Chicago, Illinois, United States, 60208|
|Principal Investigator:||Nirmala Gonsalves, M.D.||Northwestern University|