ConfocAl endomicroSCopy bAsed Diet Trial in IBS
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Other: Diet
- Registration Number
- NCT05097872
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 65
- Age 18-70 y/o (70 years included)
- Male or female subjects
- 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 (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.
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- 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 weeks.
- Allergy to Fluorescein, Xylocaine or Propofol
- Known celiac disease
- Following a diet interfering with the study diet in opinion of the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Soy exclusion diet 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. Real diet Diet Diet excluding the trigger nutrient identified by an acute mucosal reaction in CLE Wheat exclusion diet 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. Sham diet Diet Diet excluding a sham nutrient without acute mucosal reaction in CLE
- Primary Outcome Measures
Name Time Method Responder rates in targeted diet vs sham diet After 4 weeks of dietary intervention Response defined by an improvement of minimum 50 points in the IBS-SSS.
- Secondary Outcome Measures
Name Time Method Baseline permeability measures between groups At baseline Differences in baseline permeability measures between CLE positive and negative patients and healthy volunteers using Ussing chambers
Evolution of permeability measures between dietary interventions Baseline and end of respective dietary intervention Differences in permeability measures between dietary interventions (i.e. verum, sham, wheat and soy) during the dietary interventions using urinary Lactulose/Mannitol/Sucralose ratio
Baseline mucosal immune cell composition between groups Baseline Differences in baseline mucosal mast-cell and eosinophil counts between CLE positive and negative patients
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium