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. 2025 Sep;42(9):4571-4582.
doi: 10.1007/s12325-025-03289-2. Epub 2025 Jul 23.

Evaluating the Compositional Quality of Probiotics Containing Bacillus clausii in India

Dhanasekhar Kesavelu #  1 , Sridhar Ganpathy #  2 , Pramod Jog  3 , Bhaswati Acharya  4 , Vivek Saxena  5 , Nivedita Telang  6 , Nilesh Gaikwad  7
Affiliations

Evaluating the Compositional Quality of Probiotics Containing Bacillus clausii in India

Dhanasekhar Kesavelu et al. Adv Ther. 2025 Sep.

Abstract

Introduction: The quality of probiotics is crucial for their effectiveness and safety. Many studies have found discrepancies between the claimed and the actual content of microorganisms in probiotics. However, only few studies have assessed the quality of these products in India. This study aimed to evaluate the quality of various probiotics containing Bacillus clausii in India.

Methods: Eleven commercially available probiotics containing Bacillus clausii were selected: Enterogermina® (reference product), Bifilac clausii™, Entromax®, Progermina™, Entroflora™, Novogermina™, Tufpro™, Gutgermina®, Eco-All™, Entero clausi™, and Medogermina®. Suspensions were cultured and subcultured in selective media to identify Bacillus clausii colonies. Purity, viable spore load, and antibiotic resistance were assessed.

Results: The assessed parameters varied significantly among the probiotics. Enterogermina® was contamination-free, with a spore count of 2 billion/5 mL and showed resistance to all tested antibiotics. Progermina™ and Eco-all™ had higher spore counts than claimed but were contaminated with Bacillus cereus. Contaminants were found in all products except Enterogermina® and Medogermina®. Most of the products showed no antibiotic resistance.

Conclusion: The study revealed significant differences in the quality of probiotics on the Indian market, highlighting concerns about their potency and safety. Stringent quality control is necessary to ensure consumer safety and help healthcare professionals make informed decisions.

Keywords: Bacillus clausii; Antibiotic resistance; Compositional quality; Probiotics.

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Conflict of interest statement

Declarations. Conflict of Interest: Sridhar Ganpathy has received speaking honoraria from Opella. Dhanasekhar Kesavelu, Pramod Jog, Bhaswati Acharya, and Vivek Saxena have nothing to disclose. Nilesh Gaikwad and Nivedita Telang are employees of Opella and may hold shares and/or stock options in the company. Ethical Approval: This study did not involve human participants, animal subjects, or any sensitive personal data; therefore, ethical approval was not required.

Figures

Fig. 1
Fig. 1
Viable spore counts in the different probiotic formulations. Enterogermina matched the viable spore count as stated on its product label. Progermina, Eco-all, and Medogermina exhibited higher viable spore counts. However, both Progermina and Eco-all showed contamination and Medogermina did not show resistance to tested antibiotics. Dotted line indicates the standard spore load mentioned on product label
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