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

Eosinophilic Esophagitis (EoE) Clinical Trial

— SOFEED  

Official title:

Six Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778867
• Other study ID #: 2015-1949
• Secondary ID: U54AI117804
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 20, 2016
• Est. completion date: May 29, 2019

Study information

• Verified date: May 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: May 29, 2019
• Est. primary completion date: April 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Eosinophilic Esophagitis
• Eosinophilic Esophagitis (EoE)
• Eosinophilic Gastrointestinal Disorders (EGIDs)
• Esophagitis
• Gastrointestinal Diseases

Intervention

Other:
• 1 Food Elimination Diet Therapy

• 6 Food Elimination Diet Therapy

• 6 Food Elimination Diet (after 1FED failure)

Drug:
• Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)

Locations

Country	Name	City	State
United States	Tufts University	Boston	Massachusetts
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University of California, San Diego	La Jolla	California
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Utah	Salt Lake City	Utah

Sponsors (5)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	National Center for Advancing Translational Science (NCATS), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Rare Diseases (ORD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)	6 weeks after starting treatment
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.	6 weeks after starting treatment
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	6 weeks after starting treatment
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	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.	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.	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.	6 weeks after starting treatment

External Links

•   Consortium of Eosinophilic Gastrointestinal Disease Researchers