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Randomized Controlled Trial
. 2024 Sep 1;119(9):1901-1912.
doi: 10.14309/ajg.0000000000002862. Epub 2024 May 8.

A Multicenter Randomized Controlled Trial of Microbiome-Based Artificial Intelligence-Assisted Personalized Diet vs Low-Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols Diet: A Novel Approach for the Management of Irritable Bowel Syndrome

Varol Tunali  1 , Naciye Çiğdem Arslan  2 , Beyza Hilal Ermiş  3 , Gözde Derviş Hakim  4 , Aycan Gündoğdu  5 , Mehmet Hora  6 , Özkan Ufuk Nalbantoğlu  6
Affiliations
Randomized Controlled Trial

A Multicenter Randomized Controlled Trial of Microbiome-Based Artificial Intelligence-Assisted Personalized Diet vs Low-Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols Diet: A Novel Approach for the Management of Irritable Bowel Syndrome

Varol Tunali et al. Am J Gastroenterol. .

Abstract

Introduction: Personalized management strategies are pivotal in addressing irritable bowel syndrome (IBS). This multicenter randomized controlled trial focuses on comparing the efficacy of a microbiome-based artificial intelligence-assisted personalized diet (PD) with a low-fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet (FODMAP) for IBS management.

Methods: One hundred twenty-one patients participated, with 70 assigned to the PD group and 51 to the FODMAP diet group. IBS subtypes, demographics, symptom severity (IBS-SSS), anxiety, depression, and quality of life (IBS-QOL) were evaluated. Both interventions spanned 6 weeks. The trial's primary outcome was the within-individual difference in IBS-SSS compared between intervention groups.

Results: For the primary outcome, there was a change in IBS-SSS of -112.7 for those in the PD group vs -99.9 for those in the FODMAP diet group ( P = 0.29). Significant improvement occurred in IBS-SSS scores ( P < 0.001), frequency ( P < 0.001), abdominal distension ( P < 0.001), and life interference ( P < 0.001) in both groups. In addition, there were significant improvements in anxiety levels and IBS-QOL scores for both groups ( P < 0.001). Importantly, PD was effective in reducing IBS SSS scores across all IBS subtypes IBS-Constipation (IBS-C; P < 0.001), IBS-Diarrhea (IBS-D; P = 0.01), and IBS-Mixed (IBS-M; P < 0.001) while FODMAP diet exhibited comparable improvements in IBS-C ( P = 0.004) and IBS-M ( P < 0.001). PD intervention significantly improved IBS-QOL scores for all subtypes (IBS-C [ P < 0.001], IBS-D [ P < 0.001], and IBS-M [ P = 0.008]) while the FODMAP diet did so for the IBS-C ( P = 0.004) and IBS-D ( P = 0.022). Notably, PD intervention led to significant microbiome diversity shifts ( P < 0.05) and taxa alterations compared with FODMAP diet.

Discussion: The artificial intelligence-assisted PD emerges as a promising approach for comprehensive IBS management. With its ability to address individual variation, the PD approach demonstrates significant symptom relief, enhanced QOL, and notable diversity shifts in the gut microbiome, making it a valuable strategy in the evolving landscape of IBS care.

Trial registration: ClinicalTrials.gov NCT05646186.

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Conflict of interest statement

Guarantor of the article: Varol Tunali, MD, PhD.

Specific author contributions: V.T., N.C.A.: conceptualization. V.T., B.H.E.: data curation. Ö.U.N., B.H.E., A.G.: formal Analysis. V.T., Ö.U.N.: funding acquisition. V.T., N.C.A., G.D.H., Ö.U.N.: investigation. V.T., N.C.A., Ö.U.N.: methodology. V.T.: project administration. B.H.E., M.H., A.G.: software. Ö.U.N., M.H.: resources. V.T., Ö.U.N., A.G.: supervision. V.T., G.D.H., B.H.E.: validation. V.T., Ö.U.N.: visualization. V.T., B.H.E., Ö.U.N., A.G.: writing–original Draft. V.T., Ö.U.N., N.C.A., G.D.H., A.G.: writing–review & editing.

Financial support: This research received no external funding, but the microbiome analysis was carried out by ENBIOSIS Biotechnology. A. Gündoğdu and Ö.U. Nalbantoğlu are shareholders of ENBIOSIS Biotechnologies.

Potential competing interests: Beyza Hilal Ermis and Mehmet Hora are scientists working with ENBIOSIS Biotechnologies.

Data transparency statement: Deidentified individual participant data that underlie the reported results will be made available 3 months after publication for 5 years after the publication date at https://data.mendeley.com/. The study protocol is included as a data supplement available with the online version of this article.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
CONSORT diagram.
Figure 2.
Figure 2.
Box-and-whisker plot of total IBS-SSS scores before and after intervention for both groups. The P values within the groups are reported based on paired t tests. The P value for the comparison of score differences between 2 groups is shown at the top of the figure (independent t test). IBS-SSS, Irritable Bowel Syndrome Severity Scoring System.
Figure 3.
Figure 3.
Percentage improvement for specific scoring indices. The effect size of the improvements between the 2 interventions was calculated by Cohen effect size and reported as (h). IBS-SSS, Irritable Bowel Syndrome Severity Scoring System; IBS-QOL, IBS Quality of Life; HADS-ANX, Hospital Anxiety and Depression Scale-Anxiety; HADS-DEP, Hospital Anxiety and Depression Scale-Depression.
Figure 4.
Figure 4.
Pre and postintervention ordination in microbial Bray-Curtis diversity for the subgroups. (a) IBS-C, (b) IBS-D, (c) IBS-M groups. The P values are reported using the PERMANOVA test with 99,999 random permutations. IBS-C, IBS-Constipation; IBS-D, IBS-Diarrhea; IBS-M, IBS-Mixed.
Figure 5.
Figure 5.
Pre and postintervention change in relative abundance for (a) the Ruminococcaceae family and (b) Faecalibacterium prausnitzii.
See this image and copyright information in PMC

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