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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 Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Office of Rare Diseases (ORD) | NIH |
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The purpose of this interventional study is to test and compare the effectiveness of two elimination diets-the 1-food elimination diet (1FED, milk only) and the 6-food elimination diet (6FED, milk, egg, wheat, soy, tree nut/peanuts, and fish/shellfish). The study will also test the effectiveness of swallowed glucocorticoid therapy in some of the study participants for whom diet therapy was not effective.
This study will consist of two phases, plus a screening period. During the screening period, subject eligibility for the study will be determined. During Phase 1, qualified participants will be randomly assigned to one of two elimination diet therapies--the 1FED or the 6FED. Participants will remain on the assigned dietary therapy for 6 weeks. At the end of 6 weeks of therapy, esophageal biopsies from participant's standard of care (i.e. normal, routine care) endoscopy will be evaluated to determine disease status. Participants whose EoE is in remission (i.e. <15 eos/hpf) will be done with the study.
Participants whose EoE is still active (i.e. ≥15 eos/hpf) will have the option to continue into Phase 2 of the study. During Phase 2, participants who were on 1FED in Phase 1 will receive 6FED therapy for 6 weeks, and participants who were on 6FED during Phase 1 will receive swallowed glucocorticoid (SGC) therapy for 6 weeks. At the end of 6 weeks of therapy, esophageal biopsies from participant's standard of care (i.e. normal, routine care) endoscopy will be evaluated to determine disease status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-Food Elimination Diet (1FED) | Active Comparator | Participants eliminate milk from the diet in Phase 1 |
|
| 6-Food Elimination Diet (6FED) | Active Comparator | Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1 |
|
| 1FED Non-Responders (6FED) | Other | Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2 |
|
| 6FED Non-responders (SGC) | Other | Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 Food Elimination Diet Therapy | Other |
| ||
| 6 Food Elimination Diet Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants in Histologic Remission (<15 Eos/Hpf) | Percent of participants in histologic remission in 1FED versus 6FED groups. Remission is defined as esophageal peak eosinophil count < 15 eosinophils per high powered field (eos/hpf) | 6 weeks after starting treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants in Complete and Partial Histologic Remission | Percent of participants in complete and partial histologic remission in 1FED versus 6FED groups. Complete remission is defined as esophageal peak eosinophil count ≤ 1 eosinophils per high powered field (eos/hpf). Partial remission is defined as esophageal peak eosinophil count of 2 - 14 eos/hpf. | 6 weeks after starting treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc E Rothenberg, MD, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States | ||
| Northwestern University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36863390 | Derived | Kliewer KL, Gonsalves N, Dellon ES, Katzka DA, Abonia JP, Aceves SS, Arva NC, Besse JA, Bonis PA, Caldwell JM, Capocelli KE, Chehade M, Cianferoni A, Collins MH, Falk GW, Gupta SK, Hirano I, Krischer JP, Leung J, Martin LJ, Menard-Katcher P, Mukkada VA, Peterson KA, Shoda T, Rudman Spergel AK, Spergel JM, Yang GY, Zhang X, Furuta GT, Rothenberg ME. One-food versus six-food elimination diet therapy for the treatment of eosinophilic oesophagitis: a multicentre, randomised, open-label trial. Lancet Gastroenterol Hepatol. 2023 May;8(5):408-421. doi: 10.1016/S2468-1253(23)00012-2. Epub 2023 Feb 28. |
| Label | URL |
|---|---|
| Consortium of Eosinophilic Gastrointestinal Disease Researchers | View source |
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143 participants screened, 14 excluded (8 did not meet inclusion criteria, 1 met exclusion criteria, 5 withdrew during screening), and 129 randomized
Participants were recruited from eosinophilic esophagitis specialty clinics (10 sites) in the USA between May 20, 2016 and March 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | 1-Food Elimination Diet (1FED) | Participants eliminate milk from the diet in Phase 1 1 Food Elimination Diet Therapy |
| FG001 | 6-Food Elimination Diet (6FED) | Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1 6 Food Elimination Diet Therapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 29, 2018 | Dec 31, 2019 |
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| National Center for Advancing Translational Sciences (NCATS) |
| NIH |
Not provided
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| Other |
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| 6 Food Elimination Diet (after 1FED failure) | Other |
|
| Fluticasone Propionate, 880 mcg twice daily (after 6FED failure) | Drug |
|
|
| Percent of Participants Following SGC in Histologic Remission in Phase 2 | Percent of participants who failed 6FED in Phase 1 in histologic remission after following swallowed glucocorticoids (SGC) in Phase 2. Remission is defined as esophageal peak eosinophil count < 15 eos/hpf | 6 weeks after starting treatment |
| Percent of Participants Following 6FED in Histologic Remission in Phase 2 | Percent of participants who failed 1FED in Phase 1 in histologic remission after following 6FED in Phase 2. Remission is defined as esophageal peak eosinophil count < 15 eos/hpf | 6 weeks after starting treatment |
| Change From Baseline in Peak Eosinophil Count | Peak eosinophil counts were obtained at baseline and 6 weeks. The maximum (highest) peak eosinophil count among distal, mid, and proximal esophageal biopsies was obtained. Change in peak eosinophil count is defined as peak count at 6 weeks minus peak count at baseline. Changes in peak count are compared between 1FED and 6FED. A reduction (negative change) in peak count indicates improvement. | 6 weeks after starting treatment |
| Change From Baseline in Total Histology Scoring System | The histology scoring system (HSS) measures the severity (grade) and extent (stage) of eight histologic abnormalities in the esophagus including eosinophilic inflammation, eosinophilic abscess, eosinophilic surface layering, surface epithelial alteration, dilated intercellular spaces, basal zone hyperplasia, dyskeratotic epithelial cells, and lamina propria fibrosis. Total score is the sum of grade and stage scores from the esophageal biopsy (distal, mid, or proximal) with the highest score (worst abnormalities) divided by the maximum possible score for the biopsy. Total scores range from 0 - 2 (higher scores indicate more severe and/or extensive abnormalities). Histology scores were obtained at baseline and 6 weeks. Change in total histology scoring system (HSS) is defined as total HSS score at 6 weeks minus total HSS score at baseline. Changes in scores are compared between 1FED and 6FED. A reduction (negative change) in score indicates improvement. | 6 weeks after starting treatment |
| Change From Baseline in Total Endoscopic Reference Score | The endoscopic reference score (EREFS) utilizes standardized criteria for the presence and degree of 5 major endoscopic features (edema, fixed rings, exudates, furrows, strictures). Total score is the sum of the five feature scores from the distal and proximal esophagus. Total scores range from 0 - 18 (higher scores indicate worsening features). Endoscopic features were assessed at baseline and 6 weeks. Change in total endoscopic reference score is defined as total score at 6 weeks minus total score at baseline. Changes in scores are compared between 1FED and 6FED. A reduction (negative change) in score indicates improvement. | 6 weeks after starting treatment |
| Chicago |
| Illinois |
| 60208 |
| United States |
| Tufts University | Boston | Massachusetts | 02111 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| University of North Carolina, Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| FG002 | 1FED Non-Responders (6FED) | Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2 6 Food Elimination Diet Therapy |
| FG003 | 6FED Non-responders (SGC) | Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2 Fluticasone Propionate, 880 mcg twice daily |
| COMPLETED |
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| NOT COMPLETED |
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| Phase 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1-Food Elimination Diet (1FED) | Participants eliminate milk from the diet in Phase 1 1 Food Elimination Diet Therapy |
| BG001 | 6-Food Elimination Diet (6FED) | Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1 6 Food Elimination Diet Therapy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Peak Eosinophil Count | Maximum peak eosinophil count among distal, mid, and proximal esophageal biopsies | Clinical counts were used for study entry. Research counts (shown here) were unable to be obtained for some subjects. | Median | Inter-Quartile Range | eosinophils per high power field |
| |||||||||||||
| Histology scoring system | The histology scoring system (HSS) measures the severity (grade) and extent (stage) of histologic abnormalities in the esophagus. Total score is the sum of grade and stage scores from the esophageal biopsy (distal, mid, or proximal) with the highest score (worst abnormalities) divided by the maximum possible score for the biopsy. Total scores range from 0 - 2 (higher scores indicate more severe and/or extensive abnormalities). | Histology scoring system scores were not obtained for some subjects at baseline (slides were unavailable) | Mean | Standard Deviation | score on a scale |
| |||||||||||||
| Endoscopic Reference Score | The endoscopic reference score (EREFS) utilizes standardized criteria for the presence and degree of 5 major endoscopic features (edema, fixed rings, exudates, furrows, strictures). Total score is the sum of the five feature scores from the distal and proximal esophagus. Total scores range from 0 - 18 (higher scores indicate worsening features). | Baseline endoscopic feature scores were not obtained on some subjects | Median | Inter-Quartile Range | score on a scale |
|
| 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 Histologic Remission (<15 Eos/Hpf) | Percent of participants in histologic remission in 1FED versus 6FED groups. Remission is defined as esophageal peak eosinophil count < 15 eosinophils per high powered field (eos/hpf) | Intent to treat analysis including participants who had at least one clinical observation post randomization. Participants whose histologic remission could not be determined were imputed as treatment failures. | Posted | Number | percentage of participants | 6 weeks after starting treatment |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participants in Complete and Partial Histologic Remission | Percent of participants in complete and partial histologic remission in 1FED versus 6FED groups. Complete remission is defined as esophageal peak eosinophil count ≤ 1 eosinophils per high powered field (eos/hpf). Partial remission is defined as esophageal peak eosinophil count of 2 - 14 eos/hpf. | Intent to treat analysis including participants who had at least one clinical observation post randomization. Participants whose histologic remission could not be determined were imputed as treatment failures. | Posted | Number | percentage of participants | 6 weeks after starting treatment |
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| Secondary | Percent of Participants Following SGC in Histologic Remission in Phase 2 | Percent of participants who failed 6FED in Phase 1 in histologic remission after following swallowed glucocorticoids (SGC) in Phase 2. Remission is defined as esophageal peak eosinophil count < 15 eos/hpf | Intent to treat analysis including participants who had at least one clinical observation in Phase 2. Participants whose histologic remission could not be determined were imputed as treatment failures. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 weeks after starting treatment |
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| Secondary | Percent of Participants Following 6FED in Histologic Remission in Phase 2 | Percent of participants who failed 1FED in Phase 1 in histologic remission after following 6FED in Phase 2. Remission is defined as esophageal peak eosinophil count < 15 eos/hpf | Intent to treat analysis including participants who had at least one clinical observation in Phase 2. Participants whose histologic remission could not be determined were imputed as treatment failures. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 weeks after starting treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Peak Eosinophil Count | Peak eosinophil counts were obtained at baseline and 6 weeks. The maximum (highest) peak eosinophil count among distal, mid, and proximal esophageal biopsies was obtained. Change in peak eosinophil count is defined as peak count at 6 weeks minus peak count at baseline. Changes in peak count are compared between 1FED and 6FED. A reduction (negative change) in peak count indicates improvement. | Intent to treat analysis including participants who had at least one clinical observation post randomization. | Posted | Median | Inter-Quartile Range | eosinophils per high power field | 6 weeks after starting treatment |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Histology Scoring System | The histology scoring system (HSS) measures the severity (grade) and extent (stage) of eight histologic abnormalities in the esophagus including eosinophilic inflammation, eosinophilic abscess, eosinophilic surface layering, surface epithelial alteration, dilated intercellular spaces, basal zone hyperplasia, dyskeratotic epithelial cells, and lamina propria fibrosis. Total score is the sum of grade and stage scores from the esophageal biopsy (distal, mid, or proximal) with the highest score (worst abnormalities) divided by the maximum possible score for the biopsy. Total scores range from 0 - 2 (higher scores indicate more severe and/or extensive abnormalities). Histology scores were obtained at baseline and 6 weeks. Change in total histology scoring system (HSS) is defined as total HSS score at 6 weeks minus total HSS score at baseline. Changes in scores are compared between 1FED and 6FED. A reduction (negative change) in score indicates improvement. | Intent to treat analysis including participants who had at least one clinical observation post randomization. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks after starting treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Endoscopic Reference Score | The endoscopic reference score (EREFS) utilizes standardized criteria for the presence and degree of 5 major endoscopic features (edema, fixed rings, exudates, furrows, strictures). Total score is the sum of the five feature scores from the distal and proximal esophagus. Total scores range from 0 - 18 (higher scores indicate worsening features). Endoscopic features were assessed at baseline and 6 weeks. Change in total endoscopic reference score is defined as total score at 6 weeks minus total score at baseline. Changes in scores are compared between 1FED and 6FED. A reduction (negative change) in score indicates improvement. | Intent to treat analysis including participants who had at least one clinical observation post randomization. | Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks after starting treatment |
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From informed consent to 30 days after the cessation of treatment
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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 | 1-Food Elimination Diet (1FED) | Participants eliminate milk from the diet in Phase 1 1 Food Elimination Diet Therapy | 0 | 67 | 0 | 67 | 1 | 67 |
| EG001 | 6-Food Elimination Diet (6FED) | Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1 6 Food Elimination Diet Therapy | 0 | 62 | 0 | 62 | 2 | 62 |
| EG002 | 1FED Non-Responders (6FED) | Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2 6 Food Elimination Diet (after 1FED failure) | 0 | 21 | 0 | 21 | 0 | 21 |
| EG003 | 6FED Non-responders (SGC) | Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2 Fluticasone Propionate, 880 mcg twice daily (after 6FED failure) | 0 | 11 | 1 | 11 | 4 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bronchial Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc E. Rothenberg, MD, PhD | Cincinnati Children's Hospital Medical Center | 513-636-7177 | marc.rothenberg@cchmc.org |
| ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2019 | Apr 13, 2020 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 22, 2017 | Apr 13, 2020 | Prot_002.pdf |
| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Physician Decision |
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| Adverse Event |
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