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ConfocAl endomicroSCopy bAsed Diet Trial in IBS (CASCADE)

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Diet
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Real diet

Sham diet

Wheat exclusion diet

Soy exclusion diet

Arm Description

Diet excluding the trigger nutrient identified by an acute mucosal reaction in CLE

Diet excluding a sham nutrient without acute mucosal reaction in CLE

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.

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.

Outcomes

Primary Outcome Measures

Responder rates in targeted diet vs sham diet
Response defined by an improvement of minimum 50 points in the IBS-SSS.

Secondary Outcome Measures

Baseline permeability measures between groups
Differences in baseline permeability measures between CLE positive and negative patients and healthy volunteers using Ussing chambers
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 mucosal immune cell composition between groups
Differences in baseline mucosal mast-cell and eosinophil counts between CLE positive and negative patients

Full Information

First Posted
October 15, 2021
Last Updated
November 8, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT05097872
Brief Title
ConfocAl endomicroSCopy bAsed Diet Trial in IBS
Acronym
CASCADE
Official Title
Targeted Elimination Diet in IBS Patients Following Identification of Trigger Nutrients Using Confocal Laser Endomicroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real diet
Arm Type
Active Comparator
Arm Description
Diet excluding the trigger nutrient identified by an acute mucosal reaction in CLE
Arm Title
Sham diet
Arm Type
Sham Comparator
Arm Description
Diet excluding a sham nutrient without acute mucosal reaction in CLE
Arm Title
Wheat exclusion diet
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Soy exclusion diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
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)
Primary Outcome Measure Information:
Title
Responder rates in targeted diet vs sham diet
Description
Response defined by an improvement of minimum 50 points in the IBS-SSS.
Time Frame
After 4 weeks of dietary intervention
Secondary Outcome Measure Information:
Title
Baseline permeability measures between groups
Description
Differences in baseline permeability measures between CLE positive and negative patients and healthy volunteers using Ussing chambers
Time Frame
At baseline
Title
Evolution of permeability measures between dietary interventions
Description
Differences in permeability measures between dietary interventions (i.e. verum, sham, wheat and soy) during the dietary interventions using urinary Lactulose/Mannitol/Sucralose ratio
Time Frame
Baseline and end of respective dietary intervention
Title
Baseline mucosal immune cell composition between groups
Description
Differences in baseline mucosal mast-cell and eosinophil counts between CLE positive and negative patients
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lukas M Balsiger, MD
Phone
+32 16 37 70 90
Email
lukasmichaja.balsiger@kuleuven.be
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lukas M Balsiger, MD
Phone
+32492447624
Email
lukasmichaja.balsiger@kuleuven.be

12. IPD Sharing Statement

Plan to Share IPD
No

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ConfocAl endomicroSCopy bAsed Diet Trial in IBS

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