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New treatment option for Functional Dyspepsia
Official title Confocal Laser Endomicroscopy Based Diet in Functional Dyspepsia
ClinicalTrials.gov ID: NCT05666154
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Age 18-70 y/o (70 years included)
- Male or female people
- 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...
You likely can't join if
- 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...
See the full eligibility criteria
- Age 18-70 y/o (70 years included)
- Male or female people
- 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...
- people who are capable to understand the study and the questionnaires, and to comply with the study requirements.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.