Trial · NCT02778867

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

NCT02778867, Phase 2, Phase 3, Completed, Children's Hospital Medical Center, Cincinnati; results first posted 2020-05-26

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study. Trials, record NCT02778867. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02778867

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study
NCT number: NCT02778867
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 129 participants, actual
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Conditions: Eosinophilic Gastrointestinal Disorders (EGIDs), Eosinophilic Esophagitis (EoE)
Interventions: 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)
First posted: 2016-05-20
Last updated: 2020-05-26
Results first posted: 2020-05-26

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent of Participants in Histologic Remission (<15 Eos/Hpf)	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)
Secondary	Percent of Participants in Complete and Partial Histologic Remission	6 weeks after starting treatment	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.
Secondary	Percent of Participants Following SGC in Histologic Remission in Phase 2	6 weeks after starting treatment	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
Secondary	Percent of Participants Following 6FED in Histologic Remission in Phase 2	6 weeks after starting treatment	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
Secondary	Change From Baseline in Peak Eosinophil Count	6 weeks after starting treatment	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.
Secondary	Change From Baseline in Total Histology Scoring System	6 weeks after starting treatment	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.
Secondary	Change From Baseline in Total Endoscopic Reference Score	6 weeks after starting treatment	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.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent of Participants in Histologic Remission (<15 Eos/Hpf)	6 weeks after starting treatment	Intent to treat analysis including participants who had at least one clinical observation post randomization. Participants whose histologic remission could not be determined were imputed as treatment failures.	percentage of participants	NUMBER
SECONDARY	Percent of Participants in Complete and Partial Histologic Remission	6 weeks after starting treatment	Intent to treat analysis including participants who had at least one clinical observation post randomization. Participants whose histologic remission could not be determined were imputed as treatment failures.	percentage of participants	NUMBER
SECONDARY	Percent of Participants Following SGC in Histologic Remission in Phase 2	6 weeks after starting treatment	Intent to treat analysis including participants who had at least one clinical observation in Phase 2. Participants whose histologic remission could not be determined were imputed as treatment failures.	percentage of participants	NUMBER
SECONDARY	Percent of Participants Following 6FED in Histologic Remission in Phase 2	6 weeks after starting treatment	Intent to treat analysis including participants who had at least one clinical observation in Phase 2. Participants whose histologic remission could not be determined were imputed as treatment failures.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Peak Eosinophil Count	6 weeks after starting treatment	Intent to treat analysis including participants who had at least one clinical observation post randomization.	eosinophils per high power field	MEDIAN
SECONDARY	Change From Baseline in Total Histology Scoring System	6 weeks after starting treatment	Intent to treat analysis including participants who had at least one clinical observation post randomization.	score on a scale	MEAN
SECONDARY	Change From Baseline in Total Endoscopic Reference Score	6 weeks after starting treatment	Intent to treat analysis including participants who had at least one clinical observation post randomization.	score on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percent of Participants in Histologic Remission (<15 Eos/Hpf)	1-Food Elimination Diet (1FED)		34.3		percentage of participants
Percent of Participants in Histologic Remission (<15 Eos/Hpf)	6-Food Elimination Diet (6FED)		40.3		percentage of participants
Percent of Participants in Complete and Partial Histologic Remission	1-Food Elimination Diet (1FED)	Complete remission (≤ 1eos/hpf)	6.0		percentage of participants
Percent of Participants in Complete and Partial Histologic Remission	6-Food Elimination Diet (6FED)	Complete remission (≤ 1eos/hpf)	21.0		percentage of participants
Percent of Participants in Complete and Partial Histologic Remission	1-Food Elimination Diet (1FED)	Partial remission (2 - 14 eos/hpf)	28.4		percentage of participants
Percent of Participants in Complete and Partial Histologic Remission	6-Food Elimination Diet (6FED)	Partial remission (2 - 14 eos/hpf)	19.4		percentage of participants
Percent of Participants Following SGC in Histologic Remission in Phase 2	6FED Non-responders (SGC)		81.8	95% Confidence Interval 48.2 to 97.7	percentage of participants
Percent of Participants Following 6FED in Histologic Remission in Phase 2	1FED Non-Responders (6FED)		42.9	95% Confidence Interval 21.8 to 66.0	percentage of participants
Change From Baseline in Peak Eosinophil Count	1-Food Elimination Diet (1FED)		-18	Inter-Quartile Range -49 to 1	eosinophils per high power field
Change From Baseline in Peak Eosinophil Count	6-Food Elimination Diet (6FED)		-22	Inter-Quartile Range -36 to -5	eosinophils per high power field

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Phase 1	STARTED	1-Food Elimination Diet (1FED)	67
Phase 1	STARTED	6-Food Elimination Diet (6FED)	62
Phase 1	STARTED	1FED Non-Responders (6FED)	0
Phase 1	STARTED	6FED Non-responders (SGC)	0
Phase 1	COMPLETED	1-Food Elimination Diet (1FED)	65
Phase 1	COMPLETED	6-Food Elimination Diet (6FED)	59
Phase 1	COMPLETED	1FED Non-Responders (6FED)	0
Phase 1	COMPLETED	6FED Non-responders (SGC)	0
Phase 1	NOT COMPLETED	1-Food Elimination Diet (1FED)	2
Phase 1	NOT COMPLETED	6-Food Elimination Diet (6FED)	3

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Gastrointestinal Pain	Gastrointestinal disorders	1-Food Elimination Diet (1FED)	0	67
other	Gastrointestinal Pain	Gastrointestinal disorders	6-Food Elimination Diet (6FED)	0	62
other	Gastrointestinal Pain	Gastrointestinal disorders	1FED Non-Responders (6FED)	0	21
other	Gastrointestinal Pain	Gastrointestinal disorders	6FED Non-responders (SGC)	1	11
other	Diarrhea	Gastrointestinal disorders	1-Food Elimination Diet (1FED)	1	67
other	Diarrhea	Gastrointestinal disorders	6-Food Elimination Diet (6FED)	2	62
other	Diarrhea	Gastrointestinal disorders	1FED Non-Responders (6FED)	0	21
other	Diarrhea	Gastrointestinal disorders	6FED Non-responders (SGC)	1	11
other	Bronchial Infection	Infections and infestations	1-Food Elimination Diet (1FED)	0	67
other	Bronchial Infection	Infections and infestations	6-Food Elimination Diet (6FED)	0	62

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1-Food Elimination Diet (1FED)	0	67
Total, all-cause mortality	6-Food Elimination Diet (6FED)	0	62
Total, all-cause mortality	1FED Non-Responders (6FED)	0	21
Total, all-cause mortality	6FED Non-responders (SGC)	0	11
Total, other adverse events	1-Food Elimination Diet (1FED)	1	67
Total, other adverse events	6-Food Elimination Diet (6FED)	2	62
Total, other adverse events	1FED Non-Responders (6FED)	0	21
Total, other adverse events	6FED Non-responders (SGC)	4	11
Total, serious adverse events	1-Food Elimination Diet (1FED)	0	67
Total, serious adverse events	6-Food Elimination Diet (6FED)	0	62

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36863390	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U54AI117804	Consortium of Eosinophilic Gastrointestinal Disease Researchers	Rothenberg, Marc E.; FURUTA, GLENN T	CINCINNATI CHILDRENS HOSP MED CTR	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2014 to 2026

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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