Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia (CLEFD)

Universitaire Ziekenhuizen KU Leuven

Status: Enrolling

Conditions: Functional Dyspepsia

Treatments: Other: Wheat exclusion diet; Other: Sham diet; Other: Soy exclusion diet; Other: Real diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05666154

S65735

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

65 participants in 4 patient groups

Real diet

Active Comparator group

Description:

Diet excluding the trigger nutrient identified by an acute mucosal reaction in CLE

Treatment:

Other: Real diet

Sham diet

Sham Comparator group

Description:

Diet excluding a sham nutrient without acute mucosal reaction in CLE

Treatment:

Other: Sham diet

Wheat exclusion diet

Active Comparator group

Description:

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.

Treatment:

Other: Wheat exclusion diet

Soy exclusion diet

Active Comparator group

Description:

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.

Treatment:

Other: Soy exclusion diet