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SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study (SOFEED)

Primary Purpose

Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis (EoE)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
1 Food Elimination Diet Therapy
6 Food Elimination Diet Therapy
6 Food Elimination Diet (after 1FED failure)
Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Gastrointestinal Disorders (EGIDs)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have diagnosis of EoE (based on consensus criteria)
  • Have histologically confirmed active disease >15 eosinophils/hpf in either distal or proximal esophagus within 12 weeks of screening visit
  • Symptomatic (have experienced symptoms within the last month prior to enrollment)
  • Proton pump inhibitor (PPI) confirmation
  • Have a negative urine pregnancy test at screening if of childbearing potential

Exclusion Criteria:

  • Have been treated with topical swallowed steroids within the last 2 months or systemic steroids within the last 3 months
  • Have pathological eosinophilia in segments of the GI tract other than the esophagus determined by local review
  • Have been diagnosed with a GI malabsorption disorder (i.e., Inflammatory bowel disease, Crohn's disease) or Celiac disease
  • Are currently on dietary therapy strictly avoiding milk or on a 6FED
  • Have concurrent H pylori gastritis or parasitic infection
  • Have history of anaphylaxis to milk (with current avoidance of milk)
  • Have previously failed strict dietary therapy clearly documented with one of these regimens or topical steroid treatment (i.e. have achieved histological remission of <15 eos/hpf after having been on fluticasone or >1mg budesonide per day).
  • Use of investigational drugs within 4 weeks (one month) prior to enrollment
  • Are concurrently receiving any of the prohibited medications for the study
  • On immunotherapy for pollen (if not on maintenance therapy) or immunoglobulin-E (IgE) -mediated food allergy
  • 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

  • University of California, San Diego
  • Northwestern University
  • Tufts University
  • Mayo Clinic
  • Icahn School of Medicine at Mount Sinai
  • University of North Carolina, Chapel Hill
  • Cincinnati Children's Hospital Medical Center
  • University of Pennsylvania
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Other

Other

Arm Label

1-Food Elimination Diet (1FED)

6-Food Elimination Diet (6FED)

1FED Non-Responders (6FED)

6FED Non-responders (SGC)

Arm Description

Participants eliminate milk from the diet in Phase 1

Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1

Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2

Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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
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
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.
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.
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.

Full Information

First Posted
October 12, 2015
Last Updated
May 18, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Allergy and Infectious Diseases (NIAID), Office of Rare Diseases (ORD), National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT02778867
Brief Title
SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
Acronym
SOFEED
Official Title
Six Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2016 (Actual)
Primary Completion Date
April 17, 2019 (Actual)
Study Completion Date
May 29, 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 Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Allergy and Infectious Diseases (NIAID), Office of Rare Diseases (ORD), National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis (EoE)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1-Food Elimination Diet (1FED)
Arm Type
Active Comparator
Arm Description
Participants eliminate milk from the diet in Phase 1
Arm Title
6-Food Elimination Diet (6FED)
Arm Type
Active Comparator
Arm Description
Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1
Arm Title
1FED Non-Responders (6FED)
Arm Type
Other
Arm Description
Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2
Arm Title
6FED Non-responders (SGC)
Arm Type
Other
Arm Description
Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2
Intervention Type
Other
Intervention Name(s)
1 Food Elimination Diet Therapy
Intervention Type
Other
Intervention Name(s)
6 Food Elimination Diet Therapy
Intervention Type
Other
Intervention Name(s)
6 Food Elimination Diet (after 1FED failure)
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)
Other Intervention Name(s)
Flovent HFA
Primary Outcome Measure Information:
Title
Percent of Participants in Histologic Remission (<15 Eos/Hpf)
Description
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)
Time Frame
6 weeks after starting treatment
Secondary Outcome Measure Information:
Title
Percent of Participants in Complete and Partial Histologic Remission
Description
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.
Time Frame
6 weeks after starting treatment
Title
Percent of Participants Following SGC in Histologic Remission in Phase 2
Description
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
Time Frame
6 weeks after starting treatment
Title
Percent of Participants Following 6FED in Histologic Remission in Phase 2
Description
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
Time Frame
6 weeks after starting treatment
Title
Change From Baseline in Peak Eosinophil Count
Description
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.
Time Frame
6 weeks after starting treatment
Title
Change From Baseline in Total Histology Scoring System
Description
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.
Time Frame
6 weeks after starting treatment
Title
Change From Baseline in Total Endoscopic Reference Score
Description
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.
Time Frame
6 weeks after starting treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have diagnosis of EoE (based on consensus criteria) Have histologically confirmed active disease >15 eosinophils/hpf in either distal or proximal esophagus within 12 weeks of screening visit Symptomatic (have experienced symptoms within the last month prior to enrollment) Proton pump inhibitor (PPI) confirmation Have a negative urine pregnancy test at screening if of childbearing potential Exclusion Criteria: Have been treated with topical swallowed steroids within the last 2 months or systemic steroids within the last 3 months Have pathological eosinophilia in segments of the GI tract other than the esophagus determined by local review Have been diagnosed with a GI malabsorption disorder (i.e., Inflammatory bowel disease, Crohn's disease) or Celiac disease Are currently on dietary therapy strictly avoiding milk or on a 6FED Have concurrent H pylori gastritis or parasitic infection Have history of anaphylaxis to milk (with current avoidance of milk) Have previously failed strict dietary therapy clearly documented with one of these regimens or topical steroid treatment (i.e. have achieved histological remission of <15 eos/hpf after having been on fluticasone or >1mg budesonide per day). Use of investigational drugs within 4 weeks (one month) prior to enrollment Are concurrently receiving any of the prohibited medications for the study On immunotherapy for pollen (if not on maintenance therapy) or immunoglobulin-E (IgE) -mediated food allergy 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
Marc E Rothenberg, MD, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Facility Name
Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.rarediseasesnetwork.org/cms/CEGIR
Description
Consortium of Eosinophilic Gastrointestinal Disease Researchers

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SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study

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