Diet modification based on mucosal reactions in functional dyspepsia
Targeted Elimination Diet in FD Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy
This study is testing whether a special diet that avoids certain foods can help people with functional dyspepsia feel better by looking at how their stomach reacts to different nutrients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05666154 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of a targeted diet on patients with functional dyspepsia by using confocal laser endomicroscopy to observe mucosal reactions to different nutrients. After a baseline assessment, patients will be exposed to various nutrients, and those who show acute mucosal reactions will follow a diet excluding the triggering nutrient for four weeks. The study employs a randomized, blinded crossover design to compare the effects of the real diet against a sham diet. The goal is to understand the symptomatic response to dietary changes and the underlying mechanisms of mucosal reactions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 diagnosed with functional dyspepsia according to Rome IV criteria.
Not a fit: Patients who are pregnant, breastfeeding, or have a history of major gastrointestinal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to personalized dietary recommendations that alleviate symptoms of functional dyspepsia.
How similar studies have performed: While similar dietary interventions have been explored, this specific approach using confocal laser endomicroscopy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-70 y/o (70 years included) * Male or female subjects * FD (PDS, EPS or overlap) according to Rome IV criteria * Provide written informed consent to participate in the study * Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses. * Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements. Exclusion Criteria: * Pregnant or breastfeeding women * History of major surgery of the gastrointestinal tract (cholecystectomy and uncomplicated appendectomy are allowed) * Symptoms predominantly associated with irritable bowel syndrome or gastro-esophageal reflux disease * IgE-mediated food allergies identified by immunocaps blood tests * Known underlying organic gastrointestinal disease * Current use of NSAIDs, proton-pump inhibitors, systemic histamine-receptor antagonists, mast cell stabilizers, corticosteroids, opioids (need to be stopped at least 2 weeks). Use of antibiotics in the past 6 weeks. * Allergy to Fluorescein or Propofol * Known celiac disease * Following a diet, interfering with the study diet in opinion to the investigators
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Jolien Schol, MD
- Email: jolien.schol@kuleuven.be
- Phone: +3216345663
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.