Clinical Trial

The Six Food Elimination in Postprandial Distress Syndrome

Unknown
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Record status
This record was last updated July 3, 2024 (before its estimated January 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
The six food elimination diet, as known in eosinophilic esophagitis, will be performed in 15 patients with functional dyspepsia (subtype postprandial distress syndrome). Screening will exclude patients with allergies by performing immunocaps on blood. Before and after the 8 weeks of diet, an gastroduodenoscopy with biopsies will be performed to evaluate duodenal eosinophilia, mast cells and permeability. To evaluate gastric sensorimotor function, a gastric emptying breath test and a barostat test will be performed before and after the diet. Symptoms will be monitored with a daily diary (LPDS diary) and food intake will be evaluated during 2 weeks. If there is an improvement of symptoms during the diet, a reintroduction period will start. This period will last 6 weeks. Every 2 weeks, two food groups will be reintroduced. When there is a clear worsening in symptoms, a new endoscopy with biopsies will be performed.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT05651386
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Conditions Functional Dyspepsia
Enrollment 15 participants
Start Date 2020-02-19
Primary Completion 2025-01-31 (estimated)
Study Completion 2025-01-31 (estimated)
Updated on ClinicalTrials.gov 2024-07-03