Press Release

Clinical Trial Re-Confirms Role of Oral Bacteriotherapy in Hospitalized Covid-19 Patients

Lausanne, Switzerland, January 20, 2021 — Ormendes is proud to announce the results, now published in Frontiers in Nutrition, of an Italian retrospective clinical study confirming reduced mortality of hospitalized COVID-19 patients with severe pneumonia when supplemented with Sivomixx®800. 

A clinical study has confirmed the possible role of the probiotic product Sivomixx®800 as a supplement to hospitalized Covid-19 patients who are also receiving standard care. In a prior study, published last year, patients administered the same bacteriotherapy in the intensive care unit (ICU) setting were less likely to be subject to intubation and had reduced levels of diarrhea.(1)

Following these first observations, the same team of clinicians initiated a retrospective study on 200 Covid-19 ICU patients with severe pneumonia hospitalized at Policlinico Umberto I, Rome (Italy), 112 received Best Available Treatment (BAT), and 88 patients received Sivomixx®800 in addition to BAT. In this new study, investigators found a significant difference in mortality rates in evaluated groups, with 30% mortality in those treated with BAT alone and 11% in those treated with BAT plus the Siviomixx®800 bacteriotherapy.

“The significant reduction in risk of death in patients treated with both BAT and oral bacteriotherapy confirms the potential antiviral and anti-inflammatory activity exerted by the bacteria strains contained in Sivomixx®800.” said Dr G. Ceccarelli, “The effect is possibly due to the high concentration of bacteria, releasing specific enzymes which modulate the host immune response.” The specific bacterial formulation contained in Sivomixx®800 was previously tested in an Alzheimer’s mouse model and showed a protective role towards neurons and in reducing the inflammation in the brain, thus, supporting also a possible positive effect on the neurological symptoms linked with the infection by Covid-19.

The investigators further noted that, while the studies have certain limitations in their design, as the data was collected in a retrospective faction after the first major wave of the pandemic in Italy, the data does provide the medical community with a better understanding of the mechanisms of action of bacteriotherapy (Gut-Lung, Gut-Brain and Gut-Heart axes) and could help pave the way for new important applications for specific probiotic formulations.

The study is published in Frontiers in Nutrition(2).

SivoMixx®800

SivoMixx®800 is a food supplement containing different strains of lactic acid bacteria and bifidobacteria at a concentration of 800 billion CFU (Colony Forming Units) per sachet. It is not intended to treat, prevent, or cure any disease.

More information at www.sivomixx800.com

About Ormendes

Ormendes is a biotechnology company focused on the development and commercialization of live biotherapeutic medicines (www.ormendes.ch). Sivomixx®800 is a probiotic food supplement (www.sivomixx800.com)

References

  1. D’Ettorre et al. Challenges in the management of SARS-CoV2 infection: the role of oral bacteriotherapy as complementary therapeutic strategy to avoid the progression of COVID-19.  Front. Med. 2020 7:389. doi: 10.3389/fmed.2020.00389
  2. Ceccarelli et al. Oral bacteriotherapy in patients with COVID-19: a retrospective cohort study Front. Nutr. 2021 7:613928. https://doi.org/10.3389/fnut.2020.613928

Press contact

Florence Pryen, Managing Director
+41 (0)79 640 75 20
f.pryen@ormendes.ch

Press Release

Clinical Trial Re-Confirms Role of Oral Bacteriotherapy in Hospitalized Covid-19 Patients

Lausanne, Switzerland, January 20, 2021 — Ormendes is proud to announce the results, now published in Frontiers in Nutrition, of an Italian retrospective clinical study confirming reduced mortality of hospitalized COVID-19 patients with severe pneumonia when supplemented with Sivomixx®800. 

A clinical study has confirmed the possible role of the probiotic product Sivomixx®800 as a supplement to hospitalized Covid-19 patients who are also receiving standard care. In a prior study, published last year, patients administered the same bacteriotherapy in the intensive care unit (ICU) setting were less likely to be subject to intubation and had reduced levels of diarrhea.(1)

Following these first observations, the same team of clinicians initiated a retrospective study on 200 Covid-19 ICU patients with severe pneumonia hospitalized at Policlinico Umberto I, Rome (Italy), 112 received Best Available Treatment (BAT), and 88 patients received Sivomixx®800 in addition to BAT. In this new study, investigators found a significant difference in mortality rates in evaluated groups, with 30% mortality in those treated with BAT alone and 11% in those treated with BAT plus the Siviomixx®800 bacteriotherapy.

“The significant reduction in risk of death in patients treated with both BAT and oral bacteriotherapy confirms the potential antiviral and anti-inflammatory activity exerted by the bacteria strains contained in Sivomixx®800.” said Dr G. Ceccarelli, “The effect is possibly due to the high concentration of bacteria, releasing specific enzymes which modulate the host immune response.” The specific bacterial formulation contained in Sivomixx®800 was previously tested in an Alzheimer’s mouse model and showed a protective role towards neurons and in reducing the inflammation in the brain, thus, supporting also a possible positive effect on the neurological symptoms linked with the infection by Covid-19.

The investigators further noted that, while the studies have certain limitations in their design, as the data was collected in a retrospective faction after the first major wave of the pandemic in Italy, the data does provide the medical community with a better understanding of the mechanisms of action of bacteriotherapy (Gut-Lung, Gut-Brain and Gut-Heart axes) and could help pave the way for new important applications for specific probiotic formulations.

The study is published in Frontiers in Nutrition(2).

SivoMixx®800

SivoMixx®800 is a food supplement containing different strains of lactic acid bacteria and bifidobacteria at a concentration of 800 billion CFU (Colony Forming Units) per sachet. It is not intended to treat, prevent, or cure any disease.

More information at www.sivomixx800.com

About Ormendes

Ormendes is a biotechnology company focused on the development and commercialization of live biotherapeutic medicines (www.ormendes.ch). Sivomixx®800 is a probiotic food supplement (www.sivomixx800.com)

References

  1. D’Ettorre et al. Challenges in the management of SARS-CoV2 infection: the role of oral bacteriotherapy as complementary therapeutic strategy to avoid the progression of COVID-19.  Front. Med. 2020 7:389. doi: 10.3389/fmed.2020.00389
  2. Ceccarelli et al. Oral bacteriotherapy in patients with COVID-19: a retrospective cohort study Front. Nutr. 2021 7:613928. https://doi.org/10.3389/fnut.2020.613928

Press contact

Florence Pryen, Managing Director
+41 (0)79 640 75 20
f.pryen@ormendes.ch