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

Chih-Kuan Wu, I-Shiung Cheng, Yu-Chun Chung, Megan F Liu, Yung-Kai Lin, Yung-Hsiang Lin, Kristin Morris, Di Chang, Chi-Fu Chiang, Ming-Ta Yang

Journal: International journal of medical sciences 2026;23(6):1952-1965

PMID: 42158814

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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.

Address: Department of Urology, Taipei Medical University Hospital, Taipei, Taiwan.; TMU Research Center of Urology and Kidney, Taipei Medical University, Taipei, Taiwan.; Department of Physical Education, National Taichung University of Education, Taichung City, Taiwan.; Center for General Education, Taipei Medical University, Taipei, Taiwan.; School of Gerontology and Long-Term Care, College of Nursing, Taipei Medical University, Taipei, Taiwan.; Institute of Food Safety and Risk Management, National Taiwan Ocean University, Keelung, Taiwan.; Department of Food Science, National Taiwan Ocean University, Keelung, Taiwan.; Graduate Institute of Biomedical Engineering, National Chung Hsing University, Taichung, Taiwan.; Research & Design Center, TCI Co., Ltd., Taipei, Taiwan.; Amway Innovation and Science, Ada, MI, USA.; Center for General Education, Taipei Medical University, Taipei, Taiwan.; Clinical Research Center, Taipei Medical University Hospital, Taipei, Taiwan.

DOI: 10.7150/ijms.125881

MeSH Terms: Humans, Gastrointestinal Microbiome, Prebiotics, Male, Female, Adult, Middle Aged, Verrucomicrobia, Feces, Akkermansia