Elimination diet for postprandial distress syndrome
The Six Food Elimination in Postprandial Distress Syndrome
This study is testing whether a special diet that removes six types of food can help people with postprandial distress syndrome feel better after eating.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05651386 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a six food elimination diet on patients with functional dyspepsia, specifically those experiencing postprandial distress syndrome. A total of 15 participants will undergo an 8-week elimination diet, followed by a 6-week reintroduction phase if symptoms improve. Screening will involve blood tests to exclude food allergies, and participants will be monitored for symptoms using a daily diary. Gastroduodenoscopy and biopsies will be performed before and after the diet to assess changes in duodenal eosinophilia and gastric function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with functional dyspepsia and meal-related symptoms.
Not a fit: Patients with eosinophilic esophagitis or other significant gastrointestinal diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate symptoms for patients suffering from postprandial distress syndrome.
How similar studies have performed: Previous studies have shown promise with elimination diets in related conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Leuven
- KU Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Jan Tack, MD, PhD — KU Leuven
- Study coordinator: Jolien Schol, MD
- Email: jolien.schol@kuleuven.be
- Phone: 16 34 56 63
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.