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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02778867
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Hospital Medical Center, Cincinnati
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Marc E Rothenberg, MD, PhD
Principal Investigator Affiliation Children's Hospital Medical Center, Cincinnati
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis (EoE)
Study Website: View Trial Website
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, San Diego, La Jolla, California

Status

Recruiting

Address

University of California, San Diego

La Jolla, California, 92093

Site Contact

Melissa Aquino

maquino1@rchsd.org

858-576-1700 #6884

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60208

Site Contact

Angelika Zalewski

angelika.zalewski@northwestern.edu

312-695-4054

Tufts University, Boston, Massachusetts

Status

Recruiting

Address

Tufts University

Boston, Massachusetts, 02111

Site Contact

Pedro Eman

peman@tuftsmedicalcenter.org

617-636-4941

Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599

Site Contact

Sarah McGee

smcgee@med.unc.edu

919-966-4591

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Site Contact

Hilary Wilson-Perez, PhD

Hilary.Perez@cchmc.org

513-803-5074

University of Pennsylvania, Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Site Contact

Maureen Demarshall

demarshm@mail.med.upenn.edu

215-349-8546

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