Personalized diet based on food triggers identified through advanced imaging in EoE patients
Targeted Elimination Diet in EoE Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy
This study is testing whether a personalized diet, based on identifying specific food triggers through advanced imaging, can help people with eosinophilic esophagitis feel better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams Brabant) |
| Trial ID | NCT05695456 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a personalized exclusion diet for patients with eosinophilic esophagitis (EoE) by using confocal laser endomicroscopy (CLE) to identify food triggers at a cellular level. Participants will undergo a series of tests where specific foods are introduced to assess allergic reactions, followed by a 6-week personalized diet based on the results. The study is designed as a double-blind, randomized, cross-over trial, with gastroscopy and esophageal biopsies performed after each dietary phase to monitor changes. The goal is to improve patient outcomes by tailoring dietary interventions to individual responses.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with eosinophilic esophagitis who have not responded to high-dose proton pump inhibitors and experience frequent dysphagia.
Not a fit: Patients with IgE-mediated food anaphylaxis or significant gastrointestinal complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for EoE patients by providing a more effective and personalized dietary management strategy.
How similar studies have performed: Previous studies using confocal laser endomicroscopy have shown promising results in identifying food triggers in EoE patients, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eosinophilic Esophagitis, with peak eosinophil count of \>15 eos/HPF and symptoms of dysphagia at least 2 days per week * Patients have had a trial of high-dose PPI for at least 8 weeks, with either documented non-response or intolerance to the medication * Patients aged between 18 and 70 years old * Signed written informed consent * Eosinophilic Esophagitis, with peak eosinophil count of \>15 eos/HPF and symptoms of dysphagia at least 2 days per week * Patients have had a trial of high-dose PPI for at least 8 weeks, with either documented non-response or intolerance to the medication * Patients aged between 18 and 70 years old * Signed written informed consent Exclusion criteria: * IgE-mediated food anaphylaxis for 1 of the trigger nutrients * History of major gastrointestinal surgery complicating esophago-gastro-duodenoscopy * Gastro-esophageal reflux disease (GERD) Los Angeles grade C or D * Esophageal strictures, too narrow to pass with a normal gastroscope * Endoscopic dilation in the esophagus in the 4 weeks prior to inclusion * Celiac disease * Recent use (within two weeks) of non-steroidal anti-inflammatory drugs (NSAIDs), systemic histamine-receptor antagonists, mast cell stabilizers, opioids. * Proton pump inhibitors must be either stopped for at least 4 weeks, or continued on a stable dosage throughout the study period. * Corticosteroids should be stopped for at least 4 weeks. * Allergy to fluorescein, Xylocain or Propofol * Pregnant or lactating women
Where this trial is running
Leuven, Vlaams Brabant
- Jan Tack — Leuven, Vlaams Brabant, Belgium (Recruiting)
Study contacts
- Study coordinator: Jan Tack, MD PhD
- Email: jan.tack@kuleuven.be
- Phone: +3216345514
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.