Is Probiotic Strains safe?
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Safety of Probiotic Strains: A Comprehensive Review
Introduction to Probiotic Safety
Probiotics, defined as live microorganisms that confer health benefits to the host when administered in adequate amounts, have gained significant attention for their potential therapeutic benefits. However, the safety of these microorganisms is a critical concern, especially as new strains are continuously developed and commercialized .
Historical Safety of Traditional Probiotics
Lactic acid bacteria (LAB) and bifidobacteria, commonly used in probiotics, have a long history of safe use in foods and pharmaceutical preparations. These strains are generally recognized as safe (GRAS) due to their extensive use in fermented foods and their presence in the human gastrointestinal tract . However, the emergence of new strains necessitates rigorous safety assessments to ensure they do not pose any health risks .
Safety Concerns with Novel Probiotic Strains
Pathogenicity and Infectivity
Recent reports have raised concerns about the isolation of probiotic bacteria from infection sources, highlighting the need to assess factors such as pathogenicity, infectivity, and toxicity. The potential for probiotics to cause infections, especially in immunocompromised individuals, underscores the importance of comprehensive safety evaluations.
Antibiotic Resistance
The presence of transferable antibiotic resistance genes in probiotic strains is a significant concern. These genes could potentially transfer to pathogenic bacteria, complicating treatment options. Therefore, it is crucial to screen probiotic strains for antibiotic resistance and ensure they do not harbor transferable resistance genes .
Genetic Stability and Metabolic Effects
The genetic stability of probiotic strains over time and their potential to cause deleterious metabolic effects are also critical safety considerations. Probiotics must be evaluated for their ability to maintain genetic stability and avoid promoting harmful metabolic activities .
Clinical Evidence of Probiotic Safety
Human Studies
Several clinical trials have demonstrated the safety of specific probiotic strains in humans. For instance, a study on Bifidobacterium lactis and Bacillus coagulans in patients with irritable bowel syndrome (IBS) found that both strains were well tolerated, with no significant differences in adverse events compared to placebo groups. Similarly, Lactobacillus salivarius CECT5713 was shown to be safe and well-tolerated in 6-month-old infants, with no adverse effects reported.
Animal Studies
Preclinical studies using animal models have also been employed to assess the safety of probiotics. These studies often follow guidelines from the Organization for Economic Co-operation and Development (OECD) for in vivo toxicity evaluations, providing a robust framework for assessing potential risks.
Emerging Safety Assessment Techniques
Advancements in omics technologies, such as whole genome sequencing, have revolutionized the safety assessment of probiotics. These technologies enable the identification of virulence, toxin, and antibiotic resistance genes, providing a comprehensive understanding of the genetic makeup of probiotic strains . Combining genomic data with phenotypic tests can offer a detailed picture of a strain's safety profile.
Conclusion
While traditional probiotic strains have a well-documented history of safe use, the introduction of novel strains necessitates rigorous safety assessments. Factors such as pathogenicity, antibiotic resistance, genetic stability, and metabolic effects must be thoroughly evaluated. Clinical and preclinical studies, along with advanced genomic techniques, play a crucial role in ensuring the safety of probiotics. As the field evolves, continuous monitoring and adherence to established safety guidelines will be essential to maintain public health and confidence in probiotic products.
Sources and full results
Most relevant research papers on this topic
Comprehensive approaches for assessing the safety of probiotic bacteria
Probiotics in Animal Husbandry: Applicability and Associated Risk Factors
The Efficacy and Safety of Single-Strain Probiotic Formulations Containing Bifidobacterium lactis or Bacillus coagulans in Adult Patients with Irritable Bowel Syndrome—A Randomized Double-Blind Placebo-Controlled Three-Arm Interventional Trial
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Safety and tolerance of the human milk probiotic strain Lactobacillus salivarius CECT5713 in 6-month-old children.
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Butyrate Producers as Potential Next-Generation Probiotics: Safety Assessment of the Administration of Butyricicoccus pullicaecorum to Healthy Volunteers
Demonstration of safety of probiotics -- a review.
Emerging issues in probiotic safety: 2023 perspectives
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