Can a drug let kids with EoE eat eggs and milk again? small trial aims to find out.
NCT ID NCT05247866
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tested whether the drug dupilumab can help children and young adults (ages 6 to 25) with eosinophilic esophagitis (EoE) safely reintroduce foods that normally trigger their symptoms. EoE is a condition where certain foods cause inflammation in the esophagus, and current treatments often require strict food avoidance. The trial enrolled 21 participants and measured changes in esophageal inflammation and symptom scores after adding back trigger foods while on dupilumab.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dupilumab
- What this could lead to
- If successful, this could allow children with eosinophilic esophagitis to eat foods they previously had to avoid, improving their quality of life.
- What could go wrong
- This is a very small, single-site study with only 21 participants, so results may not apply to everyone. It is also a Phase 4 trial, meaning dupilumab is already approved for other conditions, but its effect on food reintroduction is still uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
21 people
The number who actually took part.
- Started
-
Jun 2022
- Finished
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Jan 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 to 25 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males or females age 6 to 25 years 2. Diagnosis of Eosinophilic Esophagitis based on the most recent international consensus definition (Dellon et al, Gastroenterology 2019) a) History of endoscopy with a peak count of \>15 eosinophils per high powered field meeting consensus criteria for Eosinophilic Esophagitis1 3. History of either milk, egg, soy or wheat induced EoE based on the following criteria in the last two years 1. Addition of a single food lead to exacerbation of esophageal eosinophilia (increase of greater than 15 eos/hpf) or 2. Removal of a single food lead to normalization of biopsy (esophageal eosinophilia showed less than 6 eos/hpf) AND 3. History of either milk, egg, soy or wheat induced EoE based on introduction of the food and symptoms in the last 12 months 4. Weight \> 10 kg 5. Ability to remain on stable dose of Proton Pump Inhibitor (PPI) therapy throughout the study 6. Girls \> 11 years of age must have a negative urine/serum pregnancy test. 7. Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria: 1. Tracheo-esophageal fistulas, inflammatory bowel disease, Barrett's disease, or other significant inflammatory disease of the gastrointestinal tract 2. Biopsy evidence of eosinophilic infiltration in any other organ system 3. History of significant esophageal procedures e.g. sclerotherapy or esophagectomy 4. Systemic immunosuppressant usage in prior 3 months 5. Narrow caliber esophagus defined as the inability to pass a 9.5 mm endoscopy into the esophagus 6. IgE mediated reaction to food (milk, egg, soy or wheat) being introduced in the last 12 months 7. Therapy with biologic molecule (e.g. omalizumab, infliximab) in prior 12 months 8. Any factors that may pose a significant risk for undergoing anesthesia/sedation 9. Subjects undergoing any type of immunotherapy to any food (oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) within 3 months prior to Visit 1. 10. Active IgE- mediated milk, egg, wheat or soy allergy based on skin test or history (if those foods are being introduced back into the diet). 11. Allergy or known hypersensitivity to the dupilumab. 12. Subjects (or parents of subjects) with obvious excessive anxiety and unlikely to cope with the conditions of an upper Endoscopy and biopsy. 13. Past or current disease(s), which in the opinion of the Investigator or the Sponsor, may affect the subject's participation in this study, including but not limited to active autoimmune disorders, immunodeficiency, malignancy, uncontrolled diseases (hypertension, psychiatric (especially anxiety), cardiac), or other disorders (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders). 14. Participation in another clinical intervention study in the three months prior to Visit 1. 15. Subjects unable to follow the protocol and the protocol requirements. 16. Subjects on any experimental drugs or treatments. 17. Subjects unable to read/understand English or follow the protocol and the protocol requirements. 18. Subjects unable to read/understand English or follow the protocol and the protocol requirements. 19. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit or throughout the trial 20. Major elective surgeries are prohibited during the study 21. Female patients who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study 22. Women of children bearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 12 weeks after the last dose. This includes female patients who experience menarche during the study duration and who are unwilling to follow the precautions for WOCBP. 23. Chronic or acute infection requiring treatment with systemic antibiotic, antivirals, or antifungal within 2 weeks of baseline visits a. Patients maybe rescreened after infection resolves 24. Participants with active or suspected parasitic infection are excluded.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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