Prabhu Rajagopalan ¹ , Raksha Sunhare¹ , Shyamprasad Kodimule ¹ and Subhendu Nayak ² *

¹ Development and Research Centre-Probiotics, Vidya Herbs Pvt Ltd, No. 102B and 105B, Pharmaceuticals SEZ Industrial area, KIDB, Hassan, 573201 Karnataka, India
² Vidya USA Corporation, 7 Otis Stone Hunter Road, Bunnell, FL 32100, USA

*Corresponding Author: Subhendu Nayak, Vidya USA Corporation, 7 Otis Stone Hunter Road, Bunnell, FL 32100, USA.

Received: January 23, 2026; Published: February 23, 2026

Abstract

Objective: This study evaluated the efficacy and safety of oral A. muciniphila supplementation (Test Product) compared to
Bifidobacterium lactis and Lactobacillus plantarum (Control Product) and placebo in individuals with irritable bowel syndrome. The
primary objective was to assess improvements in digestive symptoms; the secondary objective was to evaluate safety and tolerability.
Methods: In this multicentred, randomized controlled trial, adults (18–50 years) with irritable bowel syndrome (Rome IV criteria)
received a daily test product, a control product, or a placebo for 12 weeks. Primary outcomes included changes in irritable bowel
syndrome Symptom Severity Score. Secondary measures included quality of life, metabolic and liver parameters, stool characteristics,
and safety assessments. Intention-to-treat analyses were performed.
Results: Akkermansia muciniphila supplementation resulted in a 47% reduction in DSFQs and a significant decrease in IBS-SSS (143
to 27; p = 0.034). Notable metabolic improvements (reductions in cholesterol, triglycerides, liver enzymes) were observed with
Akkermansia muciniphila. No significant adverse events were reported; safety and tolerability were confirmed.
Conclusion: These findings indicate Akkermansia muciniphila potential as an irritable bowel syndrome treatment and emphasise the
need for larger, long-term trials to prove its mechanistic and clinical effects.
Keywords: Akkermansia muciniphila; Bifidobacterium lactis; Irritable Bowel Syndrome; Lactobacillus plantarum, Next-GenerationProbiotics

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Citation

Citation: Subhendu Nayak., et al. “A Randomized, Double-Blind, Placebo-Controlled, Parallel, Multi-Center, Phase 3 Study on Genetic and Clinical Evaluation of Probiotic Akkermansia muciniphila Strain in Patients with Irritable Bowel Syndrome". Acta Scientific Nutritional Health 10.3 (2026): 23-33.

Copyright

Copyright: © 2026 Subhendu Nayak., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.