An interventional study of baked milk product diet in Eosinophilic Esophagitis (EoE), sponsored by Shaare Zedek Medical Center. Enrolling by invitation at 1 site in Israel. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Shaare Zedek Medical Center · Not applicable, Interventional, and Treatment
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Eosinophilic esophagitis (EoE) is a chronic immune mediated disease characterized by eosinophilic infiltration in esophageal epithelium and resulting in esophageal dysfunction.
While the exact pathogenesis is yet to be elucidated, EoE is considered an atopic disease. This classification is in part due to the inflammatory infiltrate of eosinophils, basophils and T-cells producing Th2 cytokines, yet it may also be triggered by environmental allergens. In addition, the rates of atopy are approximately 3 times higher in patients with EoE than in the general population. Furthermore, and most convincing, EoE is successfully managed with dietary exclusion of triggering groups in both pediatric and adult patients, further confirming the atopic nature of the disease.
The most frequent dietary trigger for EoE is milk, but there is limited data on the effect of baked dairy . Guidelines addressing the diagnosis and treatment of EoE in both children and adults have not addressed the use of baked dairy in patients with cow's milk triggered EoE.
Restrictive diets are often challenging for patients and contribute to a reduced quality of life. Some patients tolerate baked dairy products, which are less allergenic due to denaturation of proteins through heat. The potential for baked dairy to be included in the diet of milk-triggered EoE patients remains unexplored in current guidelines.
The aim of this study is to assess tolerability and safety of baked dairy in patients with EoE in whom cow's milk has been confirmed to be a trigger food for their disease.
This prospective, multi-center trial will include patients with EoE diagnosed according to the accepted definitions: symptoms of esophageal dysfunction and >15 Eos/HPF on an esophageal biopsy, who were confirmed to have cow's milk as a trigger by demonstrating improvement during elimination and histologic relapse following reintroduction.
Following full informed consent of the patient / guardians, patients will be offered to join the trial to assess their tolerance to baked dairy.
Due to the theoretical risk of developing IgE-mediated allergy on prolonged food protein type restriction, RAST-testing or skin-prick testing to cow milk will be undertaken to exclude IgE-mediated sensitization prior to introduction of baked daury. In patients with positive results, candidates can elect to withdraw from the study or alternatively an allergist will be consulted to consider the appropriateness of a medically observed baked dairy challenge.
Strict compliance with milk-free diet will be re-enforced for not less than 6 weeks prior to the patient's closest routine follow-up endoscopy. Baseline symptom profile will be recorded. Baseline endoscopy with routine biopsies (defined below) will be performed as part of the routine scheduled follow-up endoscopy as recommended by guidelines, in order to confirm histologic remission of EoE. Patients with baseline esophageal inflammation will be excluded from the study. Patients in histologic remission will be commenced on bake dairy containing diet with not less than 1 daily serving.
Repeat symptom profile assessed at 6 weeks and at 12 weeks, with repeat endoscopy with routine biopsies at 12±2 weeks. If symptoms recur prior to 12 weeks, endoscopy may be moved up earlier, from 6 weeks onwards.
Patients in clinical and histologic remission at 12 weeks will be followed until week 52 with repeat scheduled endoscopy. Baked dairy consumption will be permitted during the follow-up, but not be required daily as in the first time period. A baked dairy consumption diary will be collected over the 4 weeks prior to this endoscopy.
235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.
This study's planned enrollment of 20 is below the median of 42 across 134 interventional studies indexed under Eosinophilic Esophagitis.
Browse Eosinophilic Esophagitis studies →Shaare Zedek Medical Center is the lead sponsor of 195 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Elimination of none baked cow milk from diet . Baked milk products containing diet.
Other: baked milk product diet
Elimination of none baked cow milk from diet . Baked cow milk containing diet.
Histologic remission rate following 12 weeks exposure to ingested baked dairy products
will be assessed on biopsies collected at week 12 during upper endoscopy
Time frame: 12 weeks exposure to ingested baked dairy products
Symptom scores following 12 weeks exposure to ingested baked dairy
Symptom profile assessed by PEESSv2.0 at 6 weeks and at 12 weeks, with repeat endoscopy with routine biopsies at 12 weeks
Time frame: 12 weeks exposure to ingested baked dairy
Endoscopic remission rate following 12 weeks exposure to ingested baked dairy
endoscopy with routine biopsies at 12 weeks
Time frame: 2 weeks exposure to ingested baked dairy
Endoscopic improvement following 12 weeks exposure to ingested baked dairy
endoscopy with routine biopsies at 12 weeks
Time frame: 12 weeks exposure to ingested baked dairy
Safety of cow's milk challenge
In patients with any prior suspicion of IgE-mediated cow's milk allergy including any suspicious rash or other symptoms on previous exposure, will be referred to a pediatric immunologist for assessment and consideration of RAST test or skin-prick test, with a supervised challenge, if deemed necessary, prior to enrollment in the trial. Number of participants without a positive RAST test or skin-prick test
Time frame: 36 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Dec 2030, 69 months after the start.
Of 23 interventional studies with no phase under Eosinophilic Esophagitis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 41. This study's planned 69 months is above that.
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