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| ID | Type | Description | Link |
|---|---|---|---|
| U54AI117804 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Office of Rare Diseases (ORD) | NIH |
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The purpose of this study is to investigate the effect of an elemental diet on adult patients with Eosinophilic Gastroenteritis
This prospective interventional study will investigate the effect of an exclusive, six week elemental diet in adult patients with Eosinophilic Gastroenteritis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | Elemental formula Intervention: Elemental Diet Therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elemental Diet Therapy | Other | Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nirmala Gonsalves, M.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60208 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37462600 | Derived | Gonsalves N, Doerfler B, Zalewski A, Yang GY, Martin LJ, Zhang X, Shoda T, Brusilovsky M, Aceves S, Thompson K, Rudman Spergel AK, Furuta G, Rothenberg ME, Hirano I. Prospective study of an amino acid-based elemental diet in an eosinophilic gastritis and gastroenteritis nutrition trial. J Allergy Clin Immunol. 2023 Sep;152(3):676-688. doi: 10.1016/j.jaci.2023.05.024. Epub 2023 Jul 18. |
| Label | URL |
|---|---|
| Related info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Elemental formula Intervention: Elemental Diet Therapy Elemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Elemental formula Intervention: Elemental Diet Therapy Elemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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)) | Posted | Number | 95% Confidence Interval | percentage of participants | 6 weeks after treatment |
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From informed consent to cessation of treatment which is approximately 8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Elemental formula Intervention: Elemental Diet Therapy Elemental Diet Therapy: Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nirmala Gonsalves | Northwestern University | 312-695-4054 | n-gonzalves@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 10, 2019 | Sep 3, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2020 | Sep 3, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C535952 | Eosinophilic enteropathy |
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| National Center for Advancing Translational Sciences (NCATS) |
| NIH |
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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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Participants |
|
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 weeks after treatment |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | eosinophil counts per high power field | Baseline, 6 weeks after treatment |
|
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6 weeks after treatment |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 6 weeks after treatment |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | T-score | Baseline, 6 weeks after treatment |
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|
| 0 |
| 18 |
| 1 |
| 18 |
| 4 |
| 18 |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
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| Common Cold | General disorders | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Syncope | Nervous system disorders | Non-systematic Assessment |
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| Title | Measurements |
|---|---|
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| Change in Pain |
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| Change in Non Pain |
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| Change in Satisfaction |
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