Eosinophilic Gastrointestinal Disorders (EGIDs)Phase 2/3SOFEEDNCT02778867
SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
A Phase 2/3 study testing 1 Food Elimination Diet Therapy, 6 Food Elimination Diet Therapy and 6 Food Elimination Diet (after 1FED failure) in people with Eosinophilic Gastrointestinal Disorders (EGIDs) and Eosinophilic Esophagitis (EoE), run by Children's Hospital Medical Center, Cincinnati at 9 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis (EoE)
- What is being tested?
- 1 Food Elimination Diet Therapy, 6 Food Elimination Diet Therapy and 6 Food Elimination Diet (after 1FED failure)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 9 sitesUnited States
- Study dates
- 20 May 2016to 29 May 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Tufts University
Boston, Massachusetts, 02111
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Northwestern University
Chicago, Illinois, 60208
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University of California, San Diego
La Jolla, California, 92093
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84132
About this study
Official title: Six Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid Trial
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.
Read the 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 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.
- Being tested
- 1 Food Elimination Diet Therapy, 6 Food Elimination Diet Therapy, 6 Food Elimination Diet (after 1FED failure), Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)
- Medical subject headings
- Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 Food Elimination Diet TherapyOther
6 Food Elimination Diet TherapyOther
6 Food Elimination Diet (after 1FED failure)Other
Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)Drug
Also called Flovent HFA
| Study group | Role | What they receive |
|---|---|---|
| 1-Food Elimination Diet (1FED) | Active comparator | Participants eliminate milk from the diet in Phase 1 Receives: Other: 1 Food Elimination Diet Therapy |
| 6-Food Elimination Diet (6FED) | Active comparator | Participants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1 Receives: Other: 6 Food Elimination Diet Therapy |
| 1FED Non-Responders (6FED) | Other | Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2 Receives: Other: 6 Food Elimination Diet (after 1FED failure) |
| 6FED Non-responders (SGC) | Other | Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2 Receives: Drug: Fluticasone Propionate, 880 mcg twice daily (after 6FED failure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 weeks after starting treatment
Secondary outcomes (6)
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.
Measured: 6 weeks after starting treatment
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
Measured: 6 weeks after starting treatment
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
Measured: 6 weeks after starting treatment
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.
Measured: 6 weeks after starting treatment
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.
Measured: 6 weeks after starting treatment
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.
Measured: 6 weeks after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start20 May 2016
- Primary completion17 Apr 2019
- Study completion29 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic Gastrointestinal Disorders (EGIDs)Studies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- 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 Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Marc E Rothenberg, MD, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778867
- Sponsor's protocol ID
- 2015-1949
- Other IDs
- U54AI117804
- Acronym
- SOFEED
- Status last verified
- May 2020
- First submitted
- 12 Oct 2015
- Last updated
- 26 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kliewer KL, Gonsalves N, Dellon ES, Katzka DA, Abonia JP, Aceves SS, Arva NC, Besse JA, Bonis PA, Caldwell JM, Capocelli KE, Chehade M, Cianferoni A, Collins MH, Falk GW, Gupta SK, Hirano I, Krischer JP, Leung J, Martin LJ, Menard-Katcher P, Mukkada VA, Peterson KA, Shoda T, Rudman Spergel AK, Spergel JM, Yang GY, Zhang X, Furuta GT, Rothenberg ME. One-food versus six-food elimination diet therapy for the treatment of eosinophilic oesophagitis: a multicentre, randomised, open-label trial. Lancet Gastroenterol Hepatol. 2023 May;8(5):408-421. doi: 10.1016/S2468-1253(23)00012-2. Epub 2023 Feb 28.
PubMed 36863390
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Six Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid Trial
- ClinicalTrials.gov ID
- NCT02778867
- Acronym / sponsor ID
- SOFEED / 2015-1949
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- 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 Sciences (NCATS)
- Study start
- 20 May 2016 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 29 May 2019 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Posted 26 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1-Food Elimination Diet (1FED) | Active comparator | Other: 1 Food Elimination Diet TherapyParticipants eliminate milk from the diet in Phase 1 |
| 6-Food Elimination Diet (6FED) | Active comparator | Other: 6 Food Elimination Diet TherapyParticipants eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 1 |
| 1FED Non-Responders (6FED) | Other | Other: 6 Food Elimination Diet (after 1FED failure)Participants that fail to respond to 1FED in Phase 1 eliminate milk, egg, wheat, soy, nuts, fish from the diet in Phase 2 |
| 6FED Non-responders (SGC) | Other | Drug: Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 Food Elimination Diet Therapy | Other | 1-Food Elimination Diet (1FED) |
| 6 Food Elimination Diet Therapy | Other | 6-Food Elimination Diet (6FED) |
| 6 Food Elimination Diet (after 1FED failure) | Other | 1FED Non-Responders (6FED) |
| Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)Also: Flovent HFA | Drug | 6FED Non-responders (SGC) |
Primary outcome
Percent of Participants in Histologic Remission (<15 Eos/Hpf)
Time frame: 6 weeks after starting treatment
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 secondary outcomes
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
Percent of Participants Following 6FED in Histologic Remission in Phase 2
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
Change From Baseline in Total Endoscopic Reference Score
Time frame: 6 weeks after starting treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36863390Kliewer KL, Gonsalves N, Dellon ES, Katzka DA, Abonia JP, Aceves SS, Arva NC, Besse JA, Bonis PA, Caldwell JM, Capocelli KE, Chehade M, Cianferoni A, Collins MH, Falk GW, Gupta SK, Hirano I, Krischer JP, Leung J, Martin LJ, Menard-Katcher P, Mukkada VA, Peterson KA, Shoda T, Rudman Spergel AK, Spergel JM, Yang GY, Zhang X, Furuta GT, Rothenberg ME. One-food versus six-food elimination diet therapy for the treatment of eosinophilic oesophagitis: a multicentre, randomised, open-label trial. Lancet Gastroenterol Hepatol. 2023 May;8(5):408-421. doi: 10.1016/S2468-1253(23)00012-2. Epub 2023 Feb 28.
- Consortium of Eosinophilic Gastrointestinal Disease ResearchersLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc E Rothenberg, MD, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 1 Food Elimination Diet Therapy, 6 Food Elimination Diet Therapy and 6 Food Elimination Diet (after 1FED failure) in people with Eosinophilic Gastrointestinal Disorders (EGIDs) and Eosinophilic Esophagitis (EoE), run by Children's Hospital Medical Center, Cincinnati at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants in Histologic Remission (<15 Eos/Hpf) (time frame: 6 weeks after starting treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02778867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020.