Targeted Elimination Diet in FD Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Responder rates in targeted diet vs sham diet
Study Overview
Brief Summary
After a thorough baseline evaluation, functional dyspepsia (FD) patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (CLE). Patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal reaction (=sham diet) from their diet for 4 weeks in a randomized, blinded crossover fashion.
The aim of the trial is to assess the symptomatic response to the targeted diet and further elucidate mechanisms underlying the acute mucosal reactions observed in CLE upon nutrient exposure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Sham diet
Diet excluding a sham nutrient without acute mucosal reaction in CLE
Intervention: Sham diet (Other)
Real diet
Diet excluding the trigger nutrient identified by an acute mucosal reaction in CLE
Intervention: Real diet (Other)
Wheat exclusion diet
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.
Intervention: Wheat exclusion diet (Other)
Soy exclusion diet
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.
Intervention: Soy exclusion diet (Other)
Outcomes
Primary Outcomes
Responder rates in targeted diet vs sham diet
Time Frame: After 4 weeks of dietary intervention
Response defined by an improvement of minimum 0.5 points on the LPDS scale
Secondary Outcomes
- Baseline duodenal transepithelial electrical resistance between groups(At baseline)
- Baseline duodenal flux of horse-radish peroxidase between groups(At baseline)
- Evolution of duodenal flux of horse-radish peroxidase between dietary interventions(Baseline and after 4 weeks of diet)
- Evolution of duodenal transepithelial electrical resistance between dietary interventions(Baseline and after 4 weeks of diet)
- Baseline mucosal immune cell composition between groups(Baseline)