Trial Outcomes & Findings for The Immune Directed Individualized Elimination Therapy (iDIET) Study (NCT NCT05543512)
NCT ID: NCT05543512
Last Updated: 2026-08-28
Results Overview
Post-treatment peak eosinophil count (measured in eos/hpf)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
68 participants
Primary outcome timeframe
8 weeks
Results posted on
2026-08-28
Participant Flow
Sixty-eight patients were assessed for eligibility and signed informed consent. Twelve did not meet inclusion criteria. Forty-seven participants received at least one exposure to a study intervention.
Participant milestones
| Measure |
Individualized Diet Elimination Therapy
Subjects in this arm will be assigned an allergen-specific immune signature-directed diet to follow for 8 weeks
|
Sham Diet Elimination Therapy
Subjects in this arm will be assigned a sham diet to follow for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
Received Intervention
|
22
|
25
|
|
Overall Study
COMPLETED
|
19
|
25
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Immune Directed Individualized Elimination Therapy (iDIET) Study
Baseline characteristics by cohort
| Measure |
Individualized Diet Elimination Therapy
n=19 Participants
Subjects in this arm will be assigned an allergen-specific immune signature-directed diet to follow for 8 weeks
|
Sham Diet Elimination Therapy
n=25 Participants
Subjects in this arm will be assigned a sham diet to follow for 8 weeks
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 9.9 • n=31 Participants
|
40.3 years
STANDARD_DEVIATION 12.3 • n=49 Participants
|
41.9 years
STANDARD_DEVIATION 11.3 • n=80 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=31 Participants
|
12 Participants
n=49 Participants
|
18 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=31 Participants
|
13 Participants
n=49 Participants
|
26 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=31 Participants
|
1 Participants
n=49 Participants
|
1 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=31 Participants
|
24 Participants
n=49 Participants
|
43 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=31 Participants
|
25 Participants
n=49 Participants
|
44 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=80 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=31 Participants
|
25 Participants
n=49 Participants
|
44 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPost-treatment peak eosinophil count (measured in eos/hpf)
Outcome measures
| Measure |
Individualized Diet Elimination Therapy
n=19 Participants
Subjects in this arm will be assigned an allergen-specific immune signature-directed diet to follow for 8 weeks
|
Sham Diet Elimination Therapy
n=25 Participants
Subjects in this arm will be assigned a sham diet to follow for 8 weeks
|
|---|---|---|
|
Post-treatment Peak Eosinophil Count
|
57.9 eos/hpf
Standard Deviation 56.9
|
116.4 eos/hpf
Standard Deviation 80.0
|
SECONDARY outcome
Timeframe: 8 weeksDysphagia symptom score, as measured by the validated Eosinophilic Esophagitis Activity Index (EEsAI) instrument This score ranges from 0-100, with higher scores indicating more severe symptoms. A score of \< 20 indicates clinical remission.
Outcome measures
| Measure |
Individualized Diet Elimination Therapy
n=19 Participants
Subjects in this arm will be assigned an allergen-specific immune signature-directed diet to follow for 8 weeks
|
Sham Diet Elimination Therapy
n=25 Participants
Subjects in this arm will be assigned a sham diet to follow for 8 weeks
|
|---|---|---|
|
Dysphagia Symptom Score
|
21.0 Scores on a scale
Standard Deviation 15.5
|
18.3 Scores on a scale
Standard Deviation 15.7
|
SECONDARY outcome
Timeframe: 8 weeksEndoscopic severity will be assessed using the validated EoE Endoscopic Reference Score (EREFS). This score measures endoscopic severity with a set of five endoscopic findings (exudates, rings, edema, furrows, and strictures), and ranges from 0-9, with higher scores indicating higher endoscopic severity.
Outcome measures
| Measure |
Individualized Diet Elimination Therapy
n=19 Participants
Subjects in this arm will be assigned an allergen-specific immune signature-directed diet to follow for 8 weeks
|
Sham Diet Elimination Therapy
n=25 Participants
Subjects in this arm will be assigned a sham diet to follow for 8 weeks
|
|---|---|---|
|
Endoscopic Severity
|
3.8 Scores on a scale
Standard Deviation 1.5
|
5.3 Scores on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 8 weeksHistologic response is defined as an esophageal eosinophil count of \<15 eos/hpf, a threshold previously determined to be optimal for response assessments in EoE studies
Outcome measures
| Measure |
Individualized Diet Elimination Therapy
n=19 Participants
Subjects in this arm will be assigned an allergen-specific immune signature-directed diet to follow for 8 weeks
|
Sham Diet Elimination Therapy
n=25 Participants
Subjects in this arm will be assigned a sham diet to follow for 8 weeks
|
|---|---|---|
|
Percentage of Histologic Responders
|
26 percent of participants
|
12 percent of participants
|
Adverse Events
Individualized Diet Elimination Therapy
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Sham Diet Elimination Therapy
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Individualized Diet Elimination Therapy
n=28 participants at risk
Subjects in this arm will be assigned an allergen-specific immune signature-directed diet to follow for 8 weeks
|
Sham Diet Elimination Therapy
n=28 participants at risk
Subjects in this arm will be assigned a sham diet to follow for 8 weeks
|
|---|---|---|
|
Investigations
Weight loss
|
7.1%
2/28 • from the time of signing informed consent through end of study, up to 16 weeks
Per the study protocol, non-serious adverse events were defined as any untoward medical occurrence: 1) Potentially related to study participation or the study device (i.e., diet elimination therapy), 2) endoscopy-related events, 3) events signaling a worsening of EoE from baseline (ex. food impactions), 4) weight loss greater than 10% since baseline, or 5) allergic reactions to foods.
|
7.1%
2/28 • from the time of signing informed consent through end of study, up to 16 weeks
Per the study protocol, non-serious adverse events were defined as any untoward medical occurrence: 1) Potentially related to study participation or the study device (i.e., diet elimination therapy), 2) endoscopy-related events, 3) events signaling a worsening of EoE from baseline (ex. food impactions), 4) weight loss greater than 10% since baseline, or 5) allergic reactions to foods.
|
|
Immune system disorders
Allergic reaction
|
7.1%
2/28 • from the time of signing informed consent through end of study, up to 16 weeks
Per the study protocol, non-serious adverse events were defined as any untoward medical occurrence: 1) Potentially related to study participation or the study device (i.e., diet elimination therapy), 2) endoscopy-related events, 3) events signaling a worsening of EoE from baseline (ex. food impactions), 4) weight loss greater than 10% since baseline, or 5) allergic reactions to foods.
|
0.00%
0/28 • from the time of signing informed consent through end of study, up to 16 weeks
Per the study protocol, non-serious adverse events were defined as any untoward medical occurrence: 1) Potentially related to study participation or the study device (i.e., diet elimination therapy), 2) endoscopy-related events, 3) events signaling a worsening of EoE from baseline (ex. food impactions), 4) weight loss greater than 10% since baseline, or 5) allergic reactions to foods.
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
2/28 • from the time of signing informed consent through end of study, up to 16 weeks
Per the study protocol, non-serious adverse events were defined as any untoward medical occurrence: 1) Potentially related to study participation or the study device (i.e., diet elimination therapy), 2) endoscopy-related events, 3) events signaling a worsening of EoE from baseline (ex. food impactions), 4) weight loss greater than 10% since baseline, or 5) allergic reactions to foods.
|
3.6%
1/28 • from the time of signing informed consent through end of study, up to 16 weeks
Per the study protocol, non-serious adverse events were defined as any untoward medical occurrence: 1) Potentially related to study participation or the study device (i.e., diet elimination therapy), 2) endoscopy-related events, 3) events signaling a worsening of EoE from baseline (ex. food impactions), 4) weight loss greater than 10% since baseline, or 5) allergic reactions to foods.
|
Additional Information
Lindsay Cortright, MA
University of North Carolina at Chapel Hill
Phone: 919-445-4911
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place