SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study (SOFEED)
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| ClinicalTrials.gov Identifier: NCT02778867 |
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Recruitment Status :
Recruiting
First Posted : May 20, 2016
Last Update Posted : January 29, 2018
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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 Science (NCATS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
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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 |
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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Phase 1
Phase 1 will evaluate the effectiveness of the 1FED and the 6FED.
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Other: elimination diet therapy
1FED: milk elimination 6FED: milk, egg, wheat, soy, fish/shellfish, and tree nuts/peanut elimination
Other Names:
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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.
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Other: elimination diet therapy
1FED: milk elimination 6FED: milk, egg, wheat, soy, fish/shellfish, and tree nuts/peanut elimination
Other Names:
Drug: Flovent Flovent (fluticasone propionate): swallowed glucocorticoid
Other Name: fluticasone propionate |
Primary Outcome Measures :
- 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 :
- 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:
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Esophagitis Eosinophilic Esophagitis Digestive System Diseases Gastrointestinal Diseases Esophageal Diseases Gastroenteritis Eosinophilia Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases 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 |