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New treatment option for Irritable Bowel Syndrome
Official title ConfocAl endomicroSCopy bAsed Diet Trial in IBS
ClinicalTrials.gov ID: NCT05097872
What this study is testing
- What it's testing
- After a thorough baseline evaluation, IBS 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
- IBS-D and IBS-M (i.e. IBS-non-C) according to Rome IV criteria
- Moderate to severe symptom severity as defined by the Irritable bowel syndrome severity scoring system (IBS-SSS) (i.e. IBS-SSS \>175 points)
- Provide written informed consent to participate in the study
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 functional dyspepsia or gastro-esophageal reflux disease
- Immunoglobuline E (IgE)-mediated food allergies identified by immunocap blood tests or skin prick testing
- Known underlying organic gastrointestinal disease
- Current or recent use of NSAIDs, proton-pump inhibitors, systemic histamine-receptor antagonists, mast cell stabilizers, corticosteroids, opioids...
See the full eligibility criteria
- Age 18-70 y/o (70 years included)
- Male or female people
- IBS-D and IBS-M (i.e. IBS-non-C) according to Rome IV criteria
- Moderate to severe symptom severity as defined by the Irritable bowel syndrome severity scoring system (IBS-SSS) (i.e. IBS-SSS \>175 points)
- 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 functional dyspepsia or gastro-esophageal reflux disease
- Immunoglobuline E (IgE)-mediated food allergies identified by immunocap blood tests or skin prick testing
- Known underlying organic gastrointestinal disease
- Current or recent 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...
- Allergy to Fluorescein, Xylocaine or Propofol
- Known celiac disease
- Following a diet interfering with the study diet in opinion of the investigator
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.