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The Six Food Elimination in Postprandial Distress Syndrome

NCT05651386 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-07-03

No results posted yet for this study

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.

Conditions

  • Functional Dyspepsia

Interventions

OTHER

Diet

No blinded, no controlled intervention.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Jan Tack, MD, PhD · KU Leuven

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-19
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05651386 on ClinicalTrials.gov