A Phase 1/2 interventional study of personalized exclusion diet based on CLE and empiric exclusion diet in Eosinophilic Esophagitis, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-06-27.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Phase 1/2, Interventional, and Diagnostic
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Among 10 studies in Eosinophilic Esophagitis with a site in Belgium — 2 open to participants now, 4 under way, 1 of them phase 3. Eosinophilic Esophagitis · Belgium.
Among the 10 studies in Eosinophilic Esophagitis with a site in Belgium, this one is the 10th largest by planned enrollment, is one of 3 that started in 2022, is the only one in phase 1/2, and was the 7th registered.
235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.
Browse Eosinophilic Esophagitis studies →2 of the 10 studies in Eosinophilic Esophagitis with a site in Belgium are open now. Recruiting first, the newest first:
Universitaire Ziekenhuizen KU Leuven · Sites in Belgium
Ages 12 mo–18 yrs
A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →
Of the 42 Eosinophilic Esophagitis studies recruiting now, 12 (29%) set no upper age limit and 27 (64%) stop at 75 or younger; 27 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4 · Phase 3 4
First in 2017; this study’s year is marked. 3 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 25 is below the median of 42 across 134 interventional studies indexed under Eosinophilic Esophagitis.
Median enrollment 146 across the 10 interventional studies. Of the 6 that completed or were terminated, 5 (83%) have results posted.
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8 of 10 have an industry lead sponsor. The 8 most frequent:
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 963 studies on the registry; 267 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Universitaire Ziekenhuizen KU Leuven has 2 studies filed under Eosinophilic Esophagitis — fewer than ten, so there is no comparison to draw.
1 of the studies in Eosinophilic Esophagitis with a site in Belgium that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06598462Uniquity One (UNI)A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis | 2027-04-30 |
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Among the 10 studies in Eosinophilic Esophagitis with a site in Belgium, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Using confocal laser endomicroscopy (CLE), gastrointestinal allergic reactions to certain foods in the duodenum will be evaluated on a cellular level. After that, a personalized exclusion diet will be followed based on the CLE results for 6 weeks, sham-controlled, in a cross-over fashion. Gastroscopy with esophageal biopsies will be repeated after each diet.
Eosinophilic esophagitis is an antigen driven esophagitis, that is characterized by symptoms of dysphagia often leading to food impaction, and that leads to strictures and esophageal motility disorders, with a significant impact on quality of life. Current treatment options include proton pump inhibitors (PPI's) and topical steroids, and also the empiric 6-food elimination diet (6FED). In this diet, the 6 most frequently implicated foods are excluded and reintroduced one by one (milk, gluten containing grains, egg, soy, nuts, fish \& shellfish). However, this is a complicated and long process, including several endoscopies with esophageal biopsies.
Confocal laser endomicroscopy (CLE) is a technique that allows to detect gastrointestinal allergic reactions in the duodenum, and to visualize them on a molecular level in real-time. The CLE probe is passed through the working channel of a standard gastroscope, up against the duodenal mucosa. After intravenous injection of fluorescein as contrast medium, the duodenal epithelium is visualized on a cellular level, including food protein mediated extravasation of fluorescein into the lumen. The 6 foods of the 6FED are sprayed on the epithelium one by one, after which a reaction is awaited. Previous use of CLE has shown that more than half of Eosinophilic esophagitis (EoE) patients reacts to one or more foods during CLE.
In this double blind randomized cross-over study the effect a personalized elimination diet, based on the reaction during CLE, is compared to a sham diet, in patients with eosinophilic esophagitis, and insufficient response or intolerance to PPI's. Both diets will be followed for 6 weeks, after which gastroscopy with esophageal biopsies will be repeated. Patients that do not have a reaction to the 6 foods will act as controls, following a control diet with milk and gluten in a cross-over fashion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
In this arm, participants who reacted to one or two nutrients during CLE will follow a personalized exclusion diet consistent of the nutrient to which they reacted, after which they will follow a sham diet in a blinded cross-over fashion.
Other: personalized exclusion diet based on CLE
In this arm, participants who reacted to one or two nutrients during CLE will follow a sham diet for 6 weeks, and than a personalized exclusion diet consistent of the nutrient to which they reacted, in a blinded cross-over fashion.
Other: personalized exclusion diet based on CLE
In this arm, participants who did not react to one of the nutrients during CLE will follow a control diet consistent of milk exclusion for 6 weeks, after which they will follow a gluten exclusion diet for 6 weeks, or the other way around.
Other: empiric exclusion diet
personalized exclusion diet based on CLE
exclusion diet with milk or gluten-containing grains
Difference in response
Difference in response (defined as normalization of peak eosinophil count in esophageal mucosal biopsies \<15 eosinophils/HPF) in patients undergoing duodenal CLE-targeted elimination diet compared to the sham diet
Time frame: 2 years
Further histological outcomes
Difference in deep remission (defined as reduction of peak eosinophil count \<6 eosinophils/HPF) before and after the targeted elimination diet respectively, compared with the sham diet
Time frame: 2 years
Further histological outcomes
Difference in peak eosinophil count (eosinophils/HPF) before and after the targeted elimination diet, compared with the sham diet
Time frame: 2 years
Symptomatic changes in patients undergoing duodenal CLE-targeted elimination diet compared to the sham diet
difference in symptoms using the DSQ (dysphagia symptom questionnaire), with a score from 0 (meaning no symptoms) to 10 (worse outcome).
Time frame: 2 years
endoscopic changes in patients undergoing duodenal CLE-targeted elimination diet compared to the sham diet
Difference in endoscopic reference score (EREFS) ranging from E0R0E0F0S0 (no endoscopic abnormalities) to E2R2E2F2S2 (worse endoscopic features)
Time frame: 2 years
change in esophageal and duodenal permeability parameters 1
using ussing chamber experiments, where human biopsies our mounted in between two chambers, and the transepithelial electrical resistance (TEER) is measured across the chambers
Time frame: 2 years
change in esophageal and duodenal permeability parameters 2
using ussing chamber experiments, where human biopsies our mounted in between two chambers, and the transepithelial flux of a high molecular weight protein is measured by labeling the molecule with a fluorescent dye.
Time frame: 2 years
Baseline and post-exposure duodenal mast cell and eosinophil counts on histology
Baseline and post-exposure duodenal mast cell and eosinophil counts on histology
Time frame: 2 years
Differences in duodenal permeability measures in CLE positive, CLE negative EoE patients and healthy controls before and after nutrient application 1
using ussing chamber experiments, where human biopsies our mounted in between two chambers, and the transepithelial electrical resistance (TEER) is measured across the chambers
Time frame: 2 years
Differences in duodenal permeability measures in CLE positive, CLE negative EoE patients and healthy controls before and after nutrient application 2
using ussing chamber experiments, where human biopsies our mounted in between two chambers, and the transepithelial flux of a high molecular weight protein is measured by labeling the molecule with a fluorescent dye.
Time frame: 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Dec 2024, 34 months after the start.
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