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Recruiting NCT05651386

The Six Food Elimination in Postprandial Distress Syndrome

Conditions: Functional Dyspepsia

Sex: All
Ages: 18 Years – 70 Years
Phase: NA
Enrollment: 15
Sponsor: Universitaire Ziekenhuizen KU Leuven

Location: Belgium

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.

Eligibility Criteria

Inclusion Criteria:Functional dyspepsia patients with meal related symptoms (Rome IV Postprandial Distress Syndrome, PDS)Witnessed written informed consent prior to any study proceduresPatients aged between 18 and 70 years inclusiveMale or female patientsWomen of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Women of non-childbearing potential may be included if surgically sterile or postmenopausal with at least 2 year without spontaneous menses.Subject is capable to understand the study and the questionnaires, and to comply with the study requirements.Exclusion Criteria:History of gastrointestinal surgery (other than appendectomy).Organic gastro-intestinal diseaseMajor psychiatric disorderPatients with eosinophilic esophagitisPresence of diabetes mellitusPresence of coeliac disease, lupus, scleroderma and other systemic auto-immune disease.Active H. Pylori infection or < 6 months after eradicationPredominant irritable bowel syndrome (IBS)Predominant gastro-oesophageal reflux disease (GERD)Atopic constitution or food allergyOngoing diet which interferes with the 6 food elimination diet.Drugs altering gastric emptying or anti-inflammatory drugsFemales who are pregnant or lactatingPatients not capable to understand or be compliant with the study.

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Source: ClinicalTrials.gov (NCT05651386). StuddyBuddy aggregates publicly available trial information.