Eosinophilic Esophagitis Caused by Food (Disorder)NCT07023380
EoE Food Test Pilot Study
A study testing Assay directed diet change in people with Eosinophilic Esophagitis Caused by Food (Disorder), run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The objective of this study is to determine the performance characteristics of a series of novel, non-invasive allergen-activated T cell assays designed to identify Eosinophilic esophagitis (EoE) causal foods, when used in conjunction with standard-of-care (SOC) practices. Read more about this study
- Who is it for?
- Ages 0 to 90 years
- Conditions the study is for
- Eosinophilic Esophagitis Caused by Food (Disorder)
- What is being tested?
- Assay directed diet change
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Eosinophilic esophagitis (EoE) based on positive esophageal biopsy (>15 eosinophils/high power field) within three months of enrollment.
- AND Intention to undergo dietary intervention for treatment of their EoE. AND Unknown contribution of one or more of milk, soy, egg, and wheat to their EoE disease state.
- AND Willingness to adopt an elimination diet based in part on the results of the experimental testing.
Who cannot join
- Proton pump inhibitor (PPI)-responsive EoE: Resolution or response of EoE to high-dose PPI (2 mg/kg) alone, at the PI's discretion.
- OR Presence of other inflammatory or infectious gastrointestinal pathology (e.g. eosinophilic gastrointestinal diseases, irritable bowel disease, Infectious Colitis, etc.), at the discretion of the Principal Investigator (PI).
- OR Prior medical or surgical history that precludes safely performing an upper endoscopy with biopsy or restriction of diet.
- OR Current immunomodulatory therapy >4 weeks (swallowed or systemic steroids, biologic therapy, chemotherapy. etc.) that may interfere with the blood test or biopsy results, at the PI's discretion.
- OR Inability to read or understand English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Pilot Interventional Study of an EoE-Causal Food Identification Blood Test
The objective of this study is to determine the performance characteristics of a series of novel, non-invasive allergen-activated T cell assays designed to identify Eosinophilic esophagitis (EoE) causal foods, when used in conjunction with standard-of-care (SOC) practices.
The question it aims to answer is:
Will assay results accurately predict EoE food allergies in concordance with SOC endoscopies after diet changes?
Read the detailed description
This proof-of-concept, interventional prospective cohort study will enroll subjects with Eosinophilic esophagitis (EoE) who have not yet identified causal foods. Subject blood will be drawn and food-activated T cell responses will be assayed. Subjects will be advised to remove foods based on standard-of-care practices and/or the outcome of their T cell assays ("personalized elimination diet"). Symptoms will be measured by the Pediatric Eosinophilic Esophagitis Symptom Scores (PEESS) Child and Parent Surveys and standard of care (SOC) endoscopy with esophageal biopsy, respectively. Response to research assay-directed diet changes will provide information about the assay's clinical value.
- Being tested
- Assay directed diet change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assay directed diet changeDiagnostic test
Functional T cell assay(s) will be performed on research subjects' peripheral blood using four foods known to commonly cause Eosinophilic esophagitis - milk, soy, egg, and wheat. Response magnitude to foods in vitro will influence whether a subject's physician chooses to recommend the subject AVOID the food or continue to CONSUME the food. Disease response to the diet changes will be evaluated in standard-of-care follow up endoscopy.
| Study group | Role | What they receive |
|---|---|---|
| EoE unknown | Experimental | Patients with Eosinophilic esophagitis who have not yet identified their disease causal foods and are interested in an elimination diet approach to disease management Receives: Diagnostic Test: Assay directed diet change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal eosinophilia (number of eosinophils in the esophagus)
Eosinophils per high power field on follow up esophageal biopsy
Measured: At least 4 weeks after implementation of diet changes
Secondary outcomes (1)
Pediatric Eosinophilic Esophagitis Symptom Score (total score based on pediatric symptom score)
Min 0-Max 100 (lower is better)
Measured: At least 4 weeks after implementation of diet changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Eosinophilic Esophagitis Caused by Food (Disorder)Studies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This pilot interventional prospective cohort study will enroll subjects with Eosinophilic esophagitis (EoE) who have not yet identified causal foods. Subject blood will be drawn and food-activated T cell responses will be assayed. Test results will be provided to subjects physician(s) to be used in conjunction with standard-of-care practices when determining which foods should be removed from the subject's diet. Symptoms and inflammation will be measured by PEESS Child and Parent Surveys and standard of care (SOC) endoscopy with esophageal biopsy, respectively. Response to research assay-aided diet changes will provide information about the assay's clinical value in a "real-world" setting.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Food Allergy Fund, American Partnership for Eosinophilic Disorders
- Responsible party
- Sponsor
- Investigators
- David A Hill, MD, PhD, Principal investigator, Children's Hospital of Philadelphia, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023380
- Sponsor's protocol ID
- 24-022349
- Status last verified
- Mar 2026
- First submitted
- 10 Jun 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers. All data that may be published or shared with other researchers will be deidentified and will not include information such as informed consent forms.
Publications
Hill DA, Spergel JM. The Immunologic Mechanisms of Eosinophilic Esophagitis. Curr Allergy Asthma Rep. 2016 Feb;16(2):9. doi: 10.1007/s11882-015-0592-3.
PubMed 26758862De Vlieger L, Smolders L, Nuyttens L, Verelst S, Breynaert C, Vanuytsel T, Hoffman I, Bullens DM. A Clinical Perspective on the Dietary Therapies for Pediatric Eosinophilic Esophagitis: The Gap Between Research and Daily Practice. Front Immunol. 2021 May 19;12:677859. doi: 10.3389/fimmu.2021.677859. eCollection 2021.
PubMed 34093578Nhu QM, Aceves SS. Tissue Remodeling in Chronic Eosinophilic Esophageal Inflammation: Parallels in Asthma and Therapeutic Perspectives. Front Med (Lausanne). 2017 Aug 7;4:128. doi: 10.3389/fmed.2017.00128. eCollection 2017.
PubMed 28831387Spergel JM, Brown-Whitehorn TF, Cianferoni A, Shuker M, Wang ML, Verma R, Liacouras CA. Identification of causative foods in children with eosinophilic esophagitis treated with an elimination diet. J Allergy Clin Immunol. 2012 Aug;130(2):461-7.e5. doi: 10.1016/j.jaci.2012.05.021. Epub 2012 Jun 27.
PubMed 22743304Dellon ES, Rusin S, Gebhart JH, Covey S, Higgins LL, Beitia R, Speck O, Woodward K, Woosley JT, Shaheen NJ. Utility of a Noninvasive Serum Biomarker Panel for Diagnosis and Monitoring of Eosinophilic Esophagitis: A Prospective Study. Am J Gastroenterol. 2015 Jun;110(6):821-7. doi: 10.1038/ajg.2015.57. Epub 2015 Mar 17.
PubMed 25781367Dilollo J, Rodriguez-Lopez EM, Wilkey L, Martin EK, Spergel JM, Hill DA. Peripheral markers of allergen-specific immune activation predict clinical allergy in eosinophilic esophagitis. Allergy. 2021 Nov;76(11):3470-3478. doi: 10.1111/all.14854. Epub 2021 May 14.
PubMed 33840099
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Interventional Study of an EoE-Causal Food Identification Blood Test
- ClinicalTrials.gov ID
- NCT07023380
- Acronym / sponsor ID
- 24-022349
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Food Allergy Fund, American Partnership for Eosinophilic Disorders
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the performance characteristics of a series of novel, non-invasive allergen-activated T cell assays designed to identify Eosinophilic esophagitis (EoE) causal foods, when used in conjunction with standard-of-care (SOC) practices.
The question it aims to answer is:
Will assay results accurately predict EoE food allergies in concordance with SOC endoscopies after diet changes?
Detailed description
This proof-of-concept, interventional prospective cohort study will enroll subjects with Eosinophilic esophagitis (EoE) who have not yet identified causal foods. Subject blood will be drawn and food-activated T cell responses will be assayed. Subjects will be advised to remove foods based on standard-of-care practices and/or the outcome of their T cell assays ("personalized elimination diet"). Symptoms will be measured by the Pediatric Eosinophilic Esophagitis Symptom Scores (PEESS) Child and Parent Surveys and standard of care (SOC) endoscopy with esophageal biopsy, respectively. Response to research assay-directed diet changes will provide information about the assay's clinical value.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This pilot interventional prospective cohort study will enroll subjects with Eosinophilic esophagitis (EoE) who have not yet identified causal foods. Subject blood will be drawn and food-activated T cell responses will be assayed. Test results will be provided to subjects physician(s) to be used in conjunction with standard-of-care practices when determining which foods should be removed from the subject's diet. Symptoms and inflammation will be measured by PEESS Child and Parent Surveys and standard of care (SOC) endoscopy with esophageal biopsy, respectively. Response to research assay-aided diet changes will provide information about the assay's clinical value in a "real-world" setting.
| Arm | Type | Receives |
|---|---|---|
| EoE unknown | Experimental | Diagnostic Test: Assay directed diet changePatients with Eosinophilic esophagitis who have not yet identified their disease causal foods and are interested in an elimination diet approach to disease management |
Who may qualify
- Ages
- 0 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Eosinophilic esophagitis (EoE) based on positive esophageal biopsy (>15 eosinophils/high power field) within three months of enrollment.
- AND Intention to undergo dietary intervention for treatment of their EoE. AND Unknown contribution of one or more of milk, soy, egg, and wheat to their EoE disease state.
- AND Willingness to adopt an elimination diet based in part on the results of the experimental testing.
Key exclusion criteria (5 listed)
- Proton pump inhibitor (PPI)-responsive EoE: Resolution or response of EoE to high-dose PPI (2 mg/kg) alone, at the PI's discretion.
- OR Presence of other inflammatory or infectious gastrointestinal pathology (e.g. eosinophilic gastrointestinal diseases, irritable bowel disease, Infectious Colitis, etc.), at the discretion of the Principal Investigator (PI).
- OR Prior medical or surgical history that precludes safely performing an upper endoscopy with biopsy or restriction of diet.
- OR Current immunomodulatory therapy >4 weeks (swallowed or systemic steroids, biologic therapy, chemotherapy. etc.) that may interfere with the blood test or biopsy results, at the PI's discretion.
- OR Inability to read or understand English.
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 |
|---|---|---|
| Assay directed diet changeFunctional T cell assay(s) will be performed on research subjects' peripheral blood using four foods known to commonly cause Eosinophilic esophagitis - milk, soy, egg, and wheat. Response magnitude to foods in vitro will influence whether a subject's physician chooses to recommend the subject AVOID the food or continue to CONSUME the food. Disease response to the diet changes will be evaluated in standard-of-care follow up endoscopy. | Diagnostic test | EoE unknown |
Primary outcome
Esophageal eosinophilia (number of eosinophils in the esophagus)
Time frame: At least 4 weeks after implementation of diet changes
Eosinophils per high power field on follow up esophageal biopsy
1 secondary outcome
Pediatric Eosinophilic Esophagitis Symptom Score (total score based on pediatric symptom score)
Time frame: At least 4 weeks after implementation of diet changes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 26758862Hill DA, Spergel JM. The Immunologic Mechanisms of Eosinophilic Esophagitis. Curr Allergy Asthma Rep. 2016 Feb;16(2):9. doi: 10.1007/s11882-015-0592-3.
- Background: PubMed 34093578De Vlieger L, Smolders L, Nuyttens L, Verelst S, Breynaert C, Vanuytsel T, Hoffman I, Bullens DM. A Clinical Perspective on the Dietary Therapies for Pediatric Eosinophilic Esophagitis: The Gap Between Research and Daily Practice. Front Immunol. 2021 May 19;12:677859. doi: 10.3389/fimmu.2021.677859. eCollection 2021.
- Background: PubMed 28831387Nhu QM, Aceves SS. Tissue Remodeling in Chronic Eosinophilic Esophageal Inflammation: Parallels in Asthma and Therapeutic Perspectives. Front Med (Lausanne). 2017 Aug 7;4:128. doi: 10.3389/fmed.2017.00128. eCollection 2017.
- Background: PubMed 22743304Spergel JM, Brown-Whitehorn TF, Cianferoni A, Shuker M, Wang ML, Verma R, Liacouras CA. Identification of causative foods in children with eosinophilic esophagitis treated with an elimination diet. J Allergy Clin Immunol. 2012 Aug;130(2):461-7.e5. doi: 10.1016/j.jaci.2012.05.021. Epub 2012 Jun 27.
- Background: PubMed 25781367Dellon ES, Rusin S, Gebhart JH, Covey S, Higgins LL, Beitia R, Speck O, Woodward K, Woosley JT, Shaheen NJ. Utility of a Noninvasive Serum Biomarker Panel for Diagnosis and Monitoring of Eosinophilic Esophagitis: A Prospective Study. Am J Gastroenterol. 2015 Jun;110(6):821-7. doi: 10.1038/ajg.2015.57. Epub 2015 Mar 17.
- Background: PubMed 33840099Dilollo J, Rodriguez-Lopez EM, Wilkey L, Martin EK, Spergel JM, Hill DA. Peripheral markers of allergen-specific immune activation predict clinical allergy in eosinophilic esophagitis. Allergy. 2021 Nov;76(11):3470-3478. doi: 10.1111/all.14854. Epub 2021 May 14.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers. All data that may be published or shared with other researchers will be deidentified and will not include information such as informed consent forms.
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.
David A Hill, MD, PhD principal investigator
Children's Hospital of Philadelphia, University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assay directed diet change in people with Eosinophilic Esophagitis Caused by Food (Disorder), run by Children's Hospital of Philadelphia at 1 site 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David A Hill, MD, PhD (215-300-0985, hilld3@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal eosinophilia (number of eosinophils in the esophagus) (time frame: At least 4 weeks after implementation of diet changes). 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 NCT07023380, which also lists 6 linked publications.
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 16 Mar 2026.