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RECRUITING
NCT05651386
NA

The Six Food Elimination in Postprandial Distress Syndrome

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2020-02-19

Completion Date

2025-01-31

Last Updated

2024-07-03

Healthy Volunteers

No

Interventions

OTHER

Diet

No blinded, no controlled intervention.

Locations (1)

KU Leuven

Leuven, Belgium