The Effects of a Prebiotic Formula Promoting Akkermansia muciniphila (AKK) on Gut Health: A Single-Centre, Randomised Controlled Trial

Abstract

Background: Gut health is closely associated with metabolic homeostasis, and alterations in gut microbiota composition have been linked to inflammation and metabolic disorders. Prebiotics targeting specific taxa, such as Akkermansia muciniphila, have attracted interest for their potential to modulate gut microbiota composition. While preclinical studies have suggested a role for A. muciniphila in gut-related metabolic pathways, clinical evidence supporting its effects on microbiome regulation and metabolic outcomes remains limited. Therefore, this study aimed to explore the effects of a prebiotic blend designed to promote A. muciniphila on gut microbiota composition and selected physiological parameters. Methods: Seventy participants were randomized to receive either placebo or the AKK formula for 8 weeks. Anthropometric assessments, blood tests, and stool examinations were performed at baseline and at weeks 4 and 8. The main analyses were conducted in the per-protocol population (n = 25 per group). Results: The results revealed no significant markers of liver or kidney dysfunction in either group. The AKK formula group showed an increased qPCR-derived relative abundance of A. muciniphila compared with total bacteria. Gut microbiome analysis further demonstrated selective changes in gut microbiota composition in the AKK formula group, including an increased relative abundance of Bifidobacterium and decreased relative abundances of Proteobacteria, Erysipelotrichia, and Escherichia-Shigella. A trend toward lower gastrointestinal discomfort scores was observed in the AKK formula group during the intervention period. Conclusions: The AKK formula increased the relative abundance of A. muciniphila, was associated with selective modulation of gut microbiota composition, and showed a trend toward reduced gastrointestinal discomfort, supporting its potential relevance in future gut health research.