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

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. Anxiety levels and IBS-QOL scores improved in both groups (P<0.001). PD reduced IBS-SSS across all subtypes (IBS-C P<0.001; IBS-D P=0.01; IBS-M P<0.001), whereas the FODMAP diet showed comparable improvements in IBS-C (P=0.004) and IBS-M (P<0.001). PD improved IBS-QOL in all subtypes (IBS-C P<0.001; IBS-D P<0.001; IBS-M P=0.008), while FODMAP improved IBS-QOL in IBS-C (P=0.004) and IBS-D (P=0.022). PD led to significant microbiome diversity shifts (P<0.05) and taxa alterations compared with FODMAP. DISCUSSION: The AI-assisted PD emerges as a promising approach for comprehensive IBS management, demonstrating symptom relief, enhanced QOL, and notable diversity shifts in the gut microbiome.