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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02778867
• Date of registration: 12/10/2015
• Prospective Registration: Yes
• Primary sponsor: Children's Hospital Medical Center, Cincinnati
• Public title: SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study SOFEED
• Scientific title: Six Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid Trial
• Date of first enrolment: May 20, 2016
• Target sample size: 129
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02778867
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• Name: Marc E Rothenberg, MD, PhD
• Affiliation: Children's Hospital Medical Center, Cincinnati

Key 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 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis (EoE)

Eosinophilic Gastrointestinal Disorders (EGIDs)

Intervention(s)

Other: 6 Food Elimination Diet Therapy

Other: 6 Food Elimination Diet (after 1FED failure)

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

Other: 1 Food Elimination Diet Therapy

Primary Outcome(s)

Percent of Participants in Histologic Remission (<15 Eos/Hpf) [Time Frame: 6 weeks after starting treatment]

Secondary Outcome(s)

Change From Baseline in Total Endoscopic Reference Score [Time Frame: 6 weeks after starting treatment]

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

Change From Baseline in Total Histology Scoring System [Time Frame: 6 weeks after starting treatment]

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

Percent of Participants in Complete and Partial Histologic Remission [Time Frame: 6 weeks after starting treatment]

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

Secondary ID(s)

U54AI117804

2015-1949

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Center for Advancing Translational Science (NCATS)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute of Allergy and Infectious Diseases (NIAID)

Office of Rare Diseases (ORD)

Results

• Results available: Yes
• Date Posted: 26/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02778867