NCT05651386 The Six Food Elimination in Postprandial Distress Syndrome
| NCT ID | NCT05651386 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Functional Dyspepsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2020-02-19 |
| Primary Completion | 2025-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2020-02-19 with a primary completion date of 2025-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 procedures * Patients aged between 18 and 70 years inclusive * Male or female patients * Women 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 disease * Major psychiatric disorder * Patients with eosinophilic esophagitis * Presence of diabetes mellitus * Presence of coeliac disease, lupus, scleroderma and other systemic auto-immune disease. * Active H. Pylori infection or \< 6 months after eradication * Predominant irritable bowel syndrome (IBS) * Predominant gastro-oesophageal reflux disease (GERD) * Atopic constitution or food allergy * Ongoing diet which interferes with the 6 food elimination diet. * Drugs altering gastric emptying or anti-inflammatory drugs * Females who are pregnant or lactating * Patients not capable to understand or be compliant with the study.
Contact & Investigator
Jan Tack, MD, PhD
PRINCIPAL INVESTIGATOR
KU Leuven
Frequently Asked Questions
Who can join the NCT05651386 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Functional Dyspepsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05651386 currently recruiting?
Yes, NCT05651386 is actively recruiting participants. Contact the research team at jolien.schol@kuleuven.be for enrollment information.
Where is the NCT05651386 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT05651386 clinical trial?
NCT05651386 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Jan Tack, MD, PhD at KU Leuven. The trial plans to enroll 15 participants.