Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia (CLEFD)
Functional Dyspepsia
About this trial
This is an interventional treatment trial for Functional Dyspepsia
Eligibility 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
Sites / Locations
- UZ LeuvenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Sham Comparator
Active Comparator
Active Comparator
Real diet
Sham diet
Wheat exclusion diet
Soy exclusion diet
Diet excluding the trigger nutrient identified by an acute mucosal reaction in CLE
Diet excluding a sham nutrient without acute mucosal reaction in CLE
In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy.
In patients without identified trigger nutrient (i.e. no acute mucosal reaction to any nutrient), wheat will be excluded as an empirical diet in crossover fashion with soy.