ConfocAl endomicroSCopy bAsed Diet Trial in IBS

Irritable Bowel Syndrome Clinical Trial

— CASCADE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05097872
• Other study ID #: S65495
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2021
• Est. completion date: October 2023

Study information

• Verified date: November 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Lukas M Balsiger, MD
• Phone: +32 16 37 70 90
• Email: lukasmichaja.balsiger[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• - 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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Other:
• Diet
Diet excluding either trigger and 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)

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Responder rates in targeted diet vs sham diet	Response defined by an improvement of minimum 50 points in the IBS-SSS.	After 4 weeks of dietary intervention
Secondary	Baseline permeability measures between groups	Differences in baseline permeability measures between CLE positive and negative patients and healthy volunteers using Ussing chambers	At baseline
Secondary	Evolution of permeability measures between dietary interventions	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 and end of respective dietary intervention
Secondary	Baseline mucosal immune cell composition between groups	Differences in baseline mucosal mast-cell and eosinophil counts between CLE positive and negative patients	Baseline