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FOOD-INDUCED ALTERATIONS IDENTIFIED USING CONFOCAL LASER ENDOMICROSCOPY ARE NOT ASSOCIATED WITH DIET OUTCOMES IN PATIENTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMISED DOUBLE BLIND CROSSOVER DIET INTERVENTION STUDY

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FOOD-INDUCED ALTERATIONS IDENTIFIED USING CONFOCAL LASER ENDOMICROSCOPY ARE NOT ASSOCIATED WITH DIET OUTCOMES IN PATIENTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMISED DOUBLE BLIND CROSSOVER DIET INTERVENTION STUDY

Lukas Balsiger 1, Jolien Schol 2, Karlien Raymenants 2, Cedric Van de Bruaene 2, Joran Toth 1, Karen Routhiaux 1, Matthias Ceulemans 3, Julie Vanderstappen 4, Astrid Verbiest 1, Michael P. Jones 5, Ricard Farré 1, Tim Vanuytsel 6, Jan Tack 2

Affiliations

1 TARGID KU Leuven, Leuven, Belgium

2 TARGID KU Leuven, Leuven, Belgium|||University Hospitals Leuven, Leuven, Belgium

3 Icahn School of Medicine at Mount Sinai, New York, United States

4 University Hospitals Leuven, Leuven, Belgium

5 Macquarie University, North Ryde, Australia

6 University Hospitals Leuven, Leuven, Belgium|||TARGID KU Leuven, Leuven, Belgium

Summary

AI Generated

A double-blind controlled cross-over trial found that confocal laser endomicroscopy-guided exclusion diets did not improve IBS symptoms more than sham diets, and mucosal alterations observed were not specific to IBS.

In 31 IBS patients who completed both diet phases, clinical response rate was 42% for CLE-guided real diet versus 36% for sham diet (odds ratio 1.33, 95% CI 0.46-3.84), with no difference in IBS-SSS change (median -30 points vs -20 points, p=0.7).
The trial was terminated prematurely for futility after interim analysis showed the odds ratio fell below the predetermined futility threshold of 1.5.
Mucosal alterations were observed in 100% of CLE exams in IBS patients (54/54 exams), either at baseline (11%) or after food administration, most commonly after milk, fish, and eggs.
Identical mucosal alterations were observed in all 15 healthy control exams (100%), with similar distribution among foods, suggesting the alterations are not disease-specific for IBS.
Acute mucosal alterations were not associated with altered permeability (25.6 vs 24.6 Ωxcm², p=0.6) or tryptase release (1.1 vs 0.62 µg/mg tissue, p=0.15).
No differences were observed between real and sham diets in pain duration, pain severity, bloating severity, or flatulence severity on visual analogue scales.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Food-induced mucosal reactions have been visualised in the duodenum of patients with irritable bowel syndrome (IBS) using confocal laser endomicroscopy (CLE). The mechanisms underlying these alterations remain elusive but uncontrolled studies have reported symptomatic improvement in patients on a diet excluding foods that triggered acute alterations.

Aims & Methods

Aim: 1/ elucidate mechanisms underlying food-induced, acute mucosal alterations and 2/ assess whether a diet based on CLE results improves symptoms in patients with IBS.
Methods: Randomised, double-blind, controlled, cross-over study. Patients with ROME IV IBS (non-C), underwent CLE with sequential administration of foods (wheat, soy, milk, egg white, fish mix, and nut mix) in a randomised order ≥2 weeks after index gastroscopy. CLE was terminated after acute reactions or after administration of all foods. In case less than three foods were administered, a second exam was scheduled. Biological measures were compared between index endoscopy and CLE with food administration. Patients excluded food(s) that did (=real diet) and food(s) that did not (=sham diet) cause alterations for 4 weeks each in a blinded, cross-over diet intervention. Clinical response rate (=improvement of ≥50 points IBS-SSS) between real and sham diet was compared. Missing data was replaced using an extreme case approach (missing data on the primary endpoint was considered non-response). Healthy controls underwent CLE to assess disease specificity of observed alterations.

Results

Thirty-three patients were included, of which 21 underwent a second CLE. Alterations were observed in all 54 exams (100%) either at baseline (6/54, 11%) or after administration of food. Acute alterations were not associated with altered permeability (transepithelial electrical resistance 25.6 Ωxcm² after CLE vs 24.6 Ωxcm²at baseline; p = 0.6) nor with tryptase release from duodenal biopsies (1.1 µg/mg tissue vs 0.62 µg/mg tissue; p =0.15) . Two patients dropped out during the diet phase (one due to maladherence to study protocol, one due to acute increase of IBS symptoms during washout). Thirty-one patients completed the diet phase: 13 were clinical responders to the real diet (42%) versus 11 responders to sham (36%). The odds ratio (OR) for clinical response to the real diet was 1.33 (95% confidence interval: 0.46-3.84). The trial was terminated prematurely for futility (predetermined futility threshold OR <1.5). There was no difference in symptom evolution between real and sham diet (median change in IBS-SSS real diet: -30 points, median change sham diet: -20 points ; p = 0.7). No differences were observed between real and sham diet regarding change in pain duration (-0.1 vs +0.1, p =0.5) , in pain severity (-0.1 vs -0.1, p = 0.9), in bloating severity (-0.1 vs -0.4, p=0.6) or in flatulence severity (± 0.0 vs -0.2 p=0.5) based on 10cm VAS scales in symptom diaries. Fifteen healthy volunteers underwent CLE with alterations in all 15 (100%) exams at baseline (2/15, 13%) or after food administration. Distribution of alterations among different foods was similar to that in patients.

Conclusion

In this double-blind controlled cross-over trial, trigger foods identified based on CLE responses were not associated with superior clinical improvement following a targeted exclusion diet compared to a sham diet. Acute alterations in healthy controls suggest these alterations are not specific for IBS. The underling physiological or pathophysiological mechanism requires further studies.

Event

UEG Week Berlin 2025

Topics

Gut Microbiota Neurogastroenterology & Motility Small Intestine & Nutrition Colorectal

Submission format

Abstract

Session

Lower GI motility II

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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