Inconclusive evidence on probiotics in a clinical setting

Currently, there are conflicting evidence regarding the benefits of probiotics in clinical settings.¹ ² In fact, a previous study identified a distinction between those who are either permissive or resistant to probiotics, based on their native microbiome.³ Furthermore, significant interindividual variability exists in the human gut microbiome, particularly when considering global populations with diverse lifestyles. This variation in the gut microbiome highlights a necessity for more personalized probiotics, as current products typically offer limited strains to all consumers.⁴

For patients being treated for conditions involving inflammation and oxidative stress, the evidence supporting efficacy of current probiotics is even less convincing. For instance, studies investigating the use of probiotics for inflammatory bowel disease (IBD) have shown no benefit in reducing remission in patients.⁵

Inconsistent & inadequate methodologies in probiotic studies

The clinical studies on probiotics vary greatly in methodology, making it difficult to determine a consensus.⁶ Many of these studies rely on observational data such as subjective reports of the patient’s well-being, and even the quantitative data often lack significance.² Diverse combinations of strains used in these studies also make it difficult to assess their overall effectiveness.¹

Lack of Usage Guidelines

There is minimal guidance on how to administer and maximize potential efficacy for probiotic intake. Basic factors such as the individual’s diet is a major influence in how well one responds to probiotics. However, such dietary guidelines still require further exploration and are not widely communicated to consumers.⁷'⁸

Inaccurate Claims in Standard Formulations

Since clinical efficacy is not a claim, dose delivery is not a priority. More than 40% of probiotic formulations categorized as drugs or as dietary supplements fail to comply with claims of use on their labels. Issues include viable cell counts lower than what is stated and inaccurate compositions of bacterial strains contained in the product.⁹

Regulatory Standards are Low

The frequent inaccuracy on probiotic labels underscores the low regulatory standards for manufacturing of probiotics classified in drugs, dietary supplements and food. Additionally, inconsistent methodologies for detecting viable cell counts and microbial strains hinder effective comparison of formulations, further emphasizing the need for improved standardized quality control measures.

Problem with Current Probiotics & LBPs

Probiotics are bacteria that can provide beneficial health effects in their host. However, there are several concerns regarding the efficacy of probiotics, especially when in an inflamed gut.

Globally >48% of human commercialized products have fewer viable cells than claimed, and >40% are not even the microbial strains claimed.

Mazzantini, D., Calvigioni, M., Celandroni, F., Lupetti, A., & Ghelardi, E. (2021). Spotlight on the compositional quality of probiotic formulations marketed worldwide. Frontiers in microbiology, 12, 693973.

At Melius MicroBiomics, our mission is to revolutionize microbiome-based therapy through the power of GEMM™. We strive to enhance medicine by offering personalized, cutting edge therapies that align with the patient’s unique microbiome. Our goal is to lead the way in microbiome-based medicine, offering better health outcomes and improving the quality of life for both humans and animals affected by these conditions.

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