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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02778867
Recruitment Status : Completed
First Posted : May 20, 2016
Results First Posted : May 26, 2020
Last Update Posted : May 26, 2020
Sponsor:
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 Science (NCATS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Eosinophilic Gastrointestinal Disorders (EGIDs) Eosinophilic Esophagitis (EoE) Other: 1 Food Elimination Diet Therapy Other: 6 Food Elimination Diet Therapy Other: 6 Food Elimination Diet (after 1FED failure) Drug: Fluticasone Propionate, 880 mcg twice daily (after 6FED failure) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Six Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid Trial
Actual Study Start Date : May 20, 2016
Actual Primary Completion Date : April 17, 2019
Actual Study Completion Date : May 29, 2019


Arm Intervention/treatment
Active Comparator: 1-Food Elimination Diet (1FED)
Participants eliminate milk from the diet in Phase 1
Other: 1 Food Elimination Diet Therapy
Active Comparator: 6-Food Elimination Diet (6FED)
Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1
Other: 6 Food Elimination Diet Therapy
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
Other: 6 Food Elimination Diet (after 1FED failure)
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
Drug: Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)
Other Name: Flovent HFA




Primary Outcome Measures :
  1. Percent of Participants in Histologic Remission (<15 Eos/Hpf) [ Time Frame: 6 weeks after starting treatment ]
    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 :
  1. Percent of Participants in Complete and Partial Histologic Remission [ Time Frame: 6 weeks after starting treatment ]
    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.

  2. Percent of Participants Following SGC in Histologic Remission in Phase 2 [ Time Frame: 6 weeks after starting treatment ]
    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

  3. Percent of Participants Following 6FED in Histologic Remission in Phase 2 [ Time Frame: 6 weeks after starting treatment ]
    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

  4. Change From Baseline in Peak Eosinophil Count [ Time Frame: 6 weeks after starting treatment ]
    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.

  5. Change From Baseline in Total Histology Scoring System [ Time Frame: 6 weeks after starting treatment ]
    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. Change From Baseline in Total Endoscopic Reference Score [ Time Frame: 6 weeks after starting treatment ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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): NCT02778867


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92093
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60208
United States, Massachusetts
Tufts University
Boston, Massachusetts, United States, 02111
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
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 Science (NCATS)
Investigators
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Principal Investigator: Marc E Rothenberg, MD, PhD Children's Hospital Medical Center, Cincinnati
  Study Documents (Full-Text)

Documents provided by Children's Hospital Medical Center, Cincinnati:
Informed Consent Form  [PDF] May 29, 2018
Statistical Analysis Plan  [PDF] October 14, 2019
Study Protocol  [PDF] November 22, 2017

Additional Information:
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02778867    
Other Study ID Numbers: 2015-1949
U54AI117804 ( U.S. NIH Grant/Contract )
First Posted: May 20, 2016    Key Record Dates
Results First Posted: May 26, 2020
Last Update Posted: May 26, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Esophagitis
Eosinophilic Esophagitis
Gastrointestinal Diseases
Digestive System Diseases
Esophageal Diseases
Gastroenteritis
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents