ConfocAl endomicroSCopy bAsed Diet Trial in IBS

NCT05097872 | Recruiting

• 1 other identifier: S65495
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Baseline permeability measures between groups

  At baseline

• Evolution of permeability measures between dietary interventions

  Baseline and end of respective dietary intervention

• Baseline mucosal immune cell composition between groups

  Baseline

Study Arms (4)

Real diet

ACTIVE COMPARATOR

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

Other: Diet

Sham diet

SHAM COMPARATOR

Diet excluding a sham nutrient without acute mucosal reaction in CLE

Other: Diet

Wheat exclusion diet

ACTIVE COMPARATOR

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.

Other: Diet

Soy exclusion diet

ACTIVE COMPARATOR

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.

Other: Diet

Interventions

Diet OTHER

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)

Real diet; Sham diet; Soy exclusion diet; Wheat exclusion diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify 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 (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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Lukas M Balsiger, MD

CONTACT

+32 16 37 70 90; lukasmichaja.balsiger@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 28, 2021
• Study Start: October 19, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)