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NCT05651386
The Six Food Elimination in Postprandial Distress Syndrome
NA trial testing Diet in Functional Dyspepsia in 15 participants. Currently enrolling.
31 January 2025
Quick facts
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 19 February 2020 |
| Primary completion | 31 January 2025 |
| Estimated completion | 31 January 2025 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Diet
Conditions studied
- Functional Dyspepsia — all drugs for Functional Dyspepsia →
Sponsor
Universitaire Ziekenhuizen KU Leuven — full company profile →
Who can join
Adults 18 to 70, any sex, with Functional Dyspepsia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Validation of the Leuven Postprandial Distress Scale According to the Rome IV Criteria for Functional Dyspepsia.
Van de Bruaene C, Carbone F, Van den Houte K, Schol J, et al · · 2026 · PMID 41492161 · DOI 10.5056/jnm25108
Verify or expand the search:
- PubMed search for NCT05651386
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Universitaire Ziekenhuizen KU Leuven trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05651386 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven
- Last refreshed: 3 July 2024
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