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NCT Number: NCT05666154

Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real diet

Other

Diet excluding either trigger nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger)

Sham Diet

Other

Diet excluding either sham nutrient in a blinded crossover fashion (CLE positive individuals with identified trigger) or wheat and soy in a blinded crossover fashion (CLE negative individuals without identified trigger)

Wheat exclusion diet

Other

Diet excluding wheat in a blinded crossover fashion (CLE negative individuals without identified trigger)

Soy exclusion diet

Other

Diet excluding soy in a blinded crossover fashion (CLE negative individuals without identified trigger)

Primary outcomes

  1. 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

  1. Baseline duodenal transepithelial electrical resistance between groups

    Time frame: At baseline

    Differences in baseline permeability measures (TEER and flux, measured with ussing chambers on duodenal biopsies) between CLE positive and negative patients and healthy volunteers using Ussing chambers

  2. Baseline duodenal flux of horse-radish peroxidase between groups

    Time frame: At baseline

    Differences in baseline permeability measures (flux, measured with ussing chambers on duodenal biopsies) between CLE positive and negative patients and healthy volunteers using Ussing chambers

  3. Evolution of duodenal flux of horse-radish peroxidase between dietary interventions

    Time frame: Baseline and after 4 weeks of diet

    Differences in permeability measures (HRP flux, measured with ussing chambers on duodenal biopsies) between dietary interventions (i.e. verum, sham, wheat and soy) during the dietary interventions using urinary Lactulose/Mannitol/Sucralose ratio

  4. Evolution of duodenal transepithelial electrical resistance between dietary interventions

    Time frame: Baseline and after 4 weeks of diet

    Differences in permeability measures (TEER, measured with ussing chambers on duodenal biopsies) between dietary interventions (i.e. verum, sham, wheat and soy) during the dietary interventions using urinary Lactulose/Mannitol/Sucralose ratio

  5. Baseline mucosal immune cell composition between groups

    Time frame: Baseline

    Differences in baseline mucosal mast-cell and eosinophil counts between CLE positive and negative patients

Study contacts

Contact information is provided by the study sponsor or research team.

Jolien Schol, MD

CONTACT

[email protected]

+3216345663

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Targeted Elimination Diet in FD Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy

Acronym: CLEFD

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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