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After a thorough baseline evaluation, functional dyspepsia (FD) patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (CLE). Patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal reaction (=sham diet) from their diet for 4 weeks in a randomized, blinded crossover fashion.
The aim of the trial is to assess the symptomatic response to the targeted diet and further elucidate mechanisms underlying the acute mucosal reactions observed in CLE upon nutrient exposure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real diet | Active Comparator | Diet excluding the trigger nutrient identified by an acute mucosal reaction in CLE |
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| Sham diet | Sham Comparator | Diet excluding a sham nutrient without acute mucosal reaction in CLE |
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| Wheat exclusion diet | Active Comparator | In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy. |
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| Soy exclusion diet | Active Comparator | In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real diet | Other | Diet excluding either trigger nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger) |
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| Measure | Description | Time Frame |
|---|---|---|
| Responder rates in targeted diet vs sham diet | Response defined by an improvement of minimum 0.5 points on the LPDS scale | After 4 weeks of dietary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline duodenal transepithelial electrical resistance between groups | Differences in baseline permeability measures (TEER and flux, measured with ussing chambers on duodenal biopsies) between CLE positive and negative patients and healthy volunteers using Ussing chambers | At baseline |
| Baseline duodenal flux of horse-radish peroxidase between groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jolien Schol, MD | Contact | +3216345663 | jolien.schol@kuleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| Sham diet | Other | Diet excluding either sham nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger) or wheat and soy in a blinded crossover fashion (CLE negative individuals without identified trigger) |
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| Wheat exclusion diet | Other | Diet excluding wheat in a blinded crossover fashion (CLE negative individuals without identified trigger) |
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| Soy exclusion diet | Other | Diet excluding soy in a blinded crossover fashion (CLE negative individuals without identified trigger) |
|
Differences in baseline permeability measures (flux, measured with ussing chambers on duodenal biopsies) between CLE positive and negative patients and healthy volunteers using Ussing chambers |
| At baseline |
| Evolution of duodenal flux of horse-radish peroxidase between dietary interventions | Differences in permeability measures (HRP flux, measured with ussing chambers on duodenal biopsies) between dietary interventions (i.e. verum, sham, wheat and soy) during the dietary interventions using urinary Lactulose/Mannitol/Sucralose ratio | Baseline and after 4 weeks of diet |
| Evolution of duodenal transepithelial electrical resistance between dietary interventions | Differences in permeability measures (TEER, measured with ussing chambers on duodenal biopsies) between dietary interventions (i.e. verum, sham, wheat and soy) during the dietary interventions using urinary Lactulose/Mannitol/Sucralose ratio | Baseline and after 4 weeks of diet |
| Baseline mucosal immune cell composition between groups | Differences in baseline mucosal mast-cell and eosinophil counts between CLE positive and negative patients | Baseline |