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Trial record 5 of 67 for:    Recruiting, Not yet recruiting, Available Studies | digestive disease | NIDDK

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

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ClinicalTrials.gov Identifier: NCT02778867
Recruitment Status : Recruiting
First Posted : May 20, 2016
Last Update Posted : January 29, 2018
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: elimination diet therapy Drug: Flovent 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 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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 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
Study Start Date : November 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Active Comparator: Phase 1
Phase 1 will evaluate the effectiveness of the 1FED and the 6FED.
Other: elimination diet therapy
1FED: milk elimination 6FED: milk, egg, wheat, soy, fish/shellfish, and tree nuts/peanut elimination
Other Names:
  • 1FED
  • 6FED
Active Comparator: Phase 2
Phase 2 will evaluate the effectiveness of the 6FED in 1FED non-responders and the effectiveness of swallowed glucocorticoids (Flovent, fluticasone propionate) in the 6FED non-responders.
Other: elimination diet therapy
1FED: milk elimination 6FED: milk, egg, wheat, soy, fish/shellfish, and tree nuts/peanut elimination
Other Names:
  • 1FED
  • 6FED
Drug: Flovent
Flovent (fluticasone propionate): swallowed glucocorticoid
Other Name: fluticasone propionate



Primary Outcome Measures :
  1. Number of participants in histologic remission (defined as < 15 eosinophils per high power field) following a six week randomized trial of one of two empiric diets (1FED or 6FED) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Number of participants in histologic remission (defined as < 15 eosinophils per high power field) following 6 weeks of swallowed glucocorticoid therapy in the 6FED diet non-responders (Phase 2). [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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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 4 weeks of screening visit
  • Symptomatic (have experienced symptoms within the last month prior to enrollment)
  • 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 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


Contacts
Contact: Hilary Wilson-Perez, PhD 513-803-5074 Hilary.Perez@cchmc.org
Contact: Tal Cohen, MS 513-517-1074 Tal.cohen@cchmc.org

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Melissa Aquino    858-576-1700 ext 6884    maquino1@rchsd.org   
Principal Investigator: Seema Aceves, M.D., PhD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60208
Contact: Angelika Zalewski    312-695-4054    angelika.zalewski@northwestern.edu   
Principal Investigator: Ikuo Hirano, M.D.         
United States, Massachusetts
Tufts University Recruiting
Boston, Massachusetts, United States, 02111
Contact: Pedro Eman    617-636-4941    peman@tuftsmedicalcenter.org   
Principal Investigator: John Leung, M.D.         
United States, North Carolina
University of North Carolina, Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Sarah McGee    919-966-4591    smcgee@med.unc.edu   
Principal Investigator: Evan Dellon, M.D., MPH         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Hilary Wilson-Perez, PhD       Hilary.Perez@cchmc.org   
Principal Investigator: Marc E Rothenberg, M.D., PhD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maureen Demarshall    215-349-8546    demarshm@mail.med.upenn.edu   
Principal Investigator: Gary Falk, M.D., MS         
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
Principal Investigator: Marc E Rothenberg, MD, PhD Children's Hospital Medical Center, Cincinnati

Additional Information:
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02778867     History of Changes
Other Study ID Numbers: 2015-1949
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases
Esophageal Diseases
Leukocyte Disorders
Hematologic Diseases
Immune System Diseases
Esophagitis
Eosinophilic Esophagitis
Gastroenteritis
Eosinophilia
Hypersensitivity, Immediate
Hypersensitivity
Fluticasone
Glucocorticoids
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists