Efficacy and Safety of a Multistrain Probiotic Formulation Depends from Manufacturing
BackgroundVariability in probiotics manufacturing may affect their properties, with potential implications for their efficacy and safety. This is of particular concern with probiotic products destined for use in patients with serious medical conditions, including human immunodeficiency virus (HIV) i...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2017-11-01
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| Series: | Frontiers in Immunology |
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| Online Access: | http://journal.frontiersin.org/article/10.3389/fimmu.2017.01474/full |
| _version_ | 1819096972766740480 |
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| author | Vito Trinchieri Luca Laghi Beatrice Vitali Carola Parolin Ilaria Giusti Daniela Capobianco Paola Mastromarino Claudio De Simone |
| author_facet | Vito Trinchieri Luca Laghi Beatrice Vitali Carola Parolin Ilaria Giusti Daniela Capobianco Paola Mastromarino Claudio De Simone |
| author_sort | Vito Trinchieri |
| collection | DOAJ |
| description | BackgroundVariability in probiotics manufacturing may affect their properties, with potential implications for their efficacy and safety. This is of particular concern with probiotic products destined for use in patients with serious medical conditions, including human immunodeficiency virus (HIV) infection. The purpose of the study was to carry out a series of experiments comparing the properties of the US-made probiotic formulation originally commercialized under the brand name VSL#3®, with those of the Italian-made formulation now commercialized under the same name. The US-made formulation has previously shown beneficial effects at the intestinal and neurological levels in HIV-infected subjects as well as in patients with inflammatory bowel diseases and hepatic encephalopathy.MethodsEleven subjects receiving combined antiretroviral therapy for HIV-1 were treated for 6 months with the US-made VSL#3 formulation. At baseline and 6 months, T-cells were analyzed for phenotype and activation markers, and fecal samples were analyzed for bifidobacteria, lactobacilli, and their metabolites. The fecal metabolome was assessed using 1H-NMR spectroscopy. Production of metabolites of interest by bacteria obtained from sachets of the two formulations was compared in vitro and their effects on a rat intestinal epithelial cell line (IEC-6) were assessed. Particular attention was paid to the metabolite 1,3-dihydroxyacetone (DHA).ResultsAt 6 months, fecal samples showed a significant increase in the specific bacterial genera contained in the probiotic supplement. Immune activation was reduced as shown by a significant reduction in the percentage of CD4+CD38+HLA-DR+ T-cells at 6 months. Fecal concentrations of DHA decreased significantly. In vitro, significant differences in the production and metabolism of DHA were found between bacteria from the US-made and Italian-made formulations: the US-made formulation was able to metabolize DHA whereas the bacteria in the Italian-made formulation were producing DHA. DHA reduced the viability of Streptococcus thermophilus, reduced IEC-6 cell viability in a dose-dependent manner, and also led to a lower rate of repair to scratched IEC-6 cell monolayer.ConclusionOur data, in conjunction with previously published findings, confirm that the new Italian-made formulation of VSL#3® is different from the previous US-made VSL#3 and therefore its efficacy and safety in HIV-infected subjects is still unproven. |
| first_indexed | 2024-12-22T00:07:41Z |
| format | Article |
| id | doaj.art-30f55337dc454d20a55a663bda09eb34 |
| institution | Directory Open Access Journal |
| issn | 1664-3224 |
| language | English |
| last_indexed | 2024-12-22T00:07:41Z |
| publishDate | 2017-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Immunology |
| spelling | doaj.art-30f55337dc454d20a55a663bda09eb342022-12-21T18:45:32ZengFrontiers Media S.A.Frontiers in Immunology1664-32242017-11-01810.3389/fimmu.2017.01474307526Efficacy and Safety of a Multistrain Probiotic Formulation Depends from ManufacturingVito Trinchieri0Luca Laghi1Beatrice Vitali2Carola Parolin3Ilaria Giusti4Daniela Capobianco5Paola Mastromarino6Claudio De Simone7Department of Public Health and Infectious Diseases, Sapienza University, Rome, ItalyDepartment of Agricultural and Food Sciences, Interdepartmental Centre for Agri-Food Industrial Research, University of Bologna, Cesena, ItalyDepartment of Pharmacy and Biotechnology, University of Bologna, Bologna, ItalyDepartment of Pharmacy and Biotechnology, University of Bologna, Bologna, ItalyDepartment of Life, Health and Environmental Sciences, University of L’Aquila, Piazzale S. Tommasi, Coppito, ItalyDepartment of Public Health and Infectious Diseases, Sapienza University, Rome, ItalyDepartment of Public Health and Infectious Disease, Section of Microbiology, Sapienza University Rome, Rome, ItalyChateau d’Oex, SwitzerlandBackgroundVariability in probiotics manufacturing may affect their properties, with potential implications for their efficacy and safety. This is of particular concern with probiotic products destined for use in patients with serious medical conditions, including human immunodeficiency virus (HIV) infection. The purpose of the study was to carry out a series of experiments comparing the properties of the US-made probiotic formulation originally commercialized under the brand name VSL#3®, with those of the Italian-made formulation now commercialized under the same name. The US-made formulation has previously shown beneficial effects at the intestinal and neurological levels in HIV-infected subjects as well as in patients with inflammatory bowel diseases and hepatic encephalopathy.MethodsEleven subjects receiving combined antiretroviral therapy for HIV-1 were treated for 6 months with the US-made VSL#3 formulation. At baseline and 6 months, T-cells were analyzed for phenotype and activation markers, and fecal samples were analyzed for bifidobacteria, lactobacilli, and their metabolites. The fecal metabolome was assessed using 1H-NMR spectroscopy. Production of metabolites of interest by bacteria obtained from sachets of the two formulations was compared in vitro and their effects on a rat intestinal epithelial cell line (IEC-6) were assessed. Particular attention was paid to the metabolite 1,3-dihydroxyacetone (DHA).ResultsAt 6 months, fecal samples showed a significant increase in the specific bacterial genera contained in the probiotic supplement. Immune activation was reduced as shown by a significant reduction in the percentage of CD4+CD38+HLA-DR+ T-cells at 6 months. Fecal concentrations of DHA decreased significantly. In vitro, significant differences in the production and metabolism of DHA were found between bacteria from the US-made and Italian-made formulations: the US-made formulation was able to metabolize DHA whereas the bacteria in the Italian-made formulation were producing DHA. DHA reduced the viability of Streptococcus thermophilus, reduced IEC-6 cell viability in a dose-dependent manner, and also led to a lower rate of repair to scratched IEC-6 cell monolayer.ConclusionOur data, in conjunction with previously published findings, confirm that the new Italian-made formulation of VSL#3® is different from the previous US-made VSL#3 and therefore its efficacy and safety in HIV-infected subjects is still unproven.http://journal.frontiersin.org/article/10.3389/fimmu.2017.01474/fullhuman immunodeficiency virusprobioticsmetabolomicsgutmicrobiotaVSL#3 |
| spellingShingle | Vito Trinchieri Luca Laghi Beatrice Vitali Carola Parolin Ilaria Giusti Daniela Capobianco Paola Mastromarino Claudio De Simone Efficacy and Safety of a Multistrain Probiotic Formulation Depends from Manufacturing Frontiers in Immunology human immunodeficiency virus probiotics metabolomics gut microbiota VSL#3 |
| title | Efficacy and Safety of a Multistrain Probiotic Formulation Depends from Manufacturing |
| title_full | Efficacy and Safety of a Multistrain Probiotic Formulation Depends from Manufacturing |
| title_fullStr | Efficacy and Safety of a Multistrain Probiotic Formulation Depends from Manufacturing |
| title_full_unstemmed | Efficacy and Safety of a Multistrain Probiotic Formulation Depends from Manufacturing |
| title_short | Efficacy and Safety of a Multistrain Probiotic Formulation Depends from Manufacturing |
| title_sort | efficacy and safety of a multistrain probiotic formulation depends from manufacturing |
| topic | human immunodeficiency virus probiotics metabolomics gut microbiota VSL#3 |
| url | http://journal.frontiersin.org/article/10.3389/fimmu.2017.01474/full |
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