Nagasaki University Announces Specific Clinical Trial Using Plasma Lactobacillus *1 (Plasma Lactobacillus is an Epibiotic) Researched and Developed by Kirin Holdings Company, Limited ("Kirin Holdings") for Patients with New Coronary Pneumonia (COVID-19) result. The findings were presented at the 63rd Annual Scientific Session of the Japanese Respiratory Society on Sunday, April 30, 2023. Nagasaki University and Kirin Holdings jointly filed a patent application for the findings of this particular clinical trial.
Current status of COVID-19
Since December 2019, COVID-19 infection has triggered multiple outbreaks, with a global infection number of 676.57 million and a death toll of 6.88 million (as of March 10, 2023). With the emergence of the Omicron variant, the number of cases in Japan has increased, and COVID-19 has become a more common infectious disease. Although SARS-CoV-2 vaccines have been widely introduced, and mild patients account for a large proportion of the affected population, for mild patients who are not at risk of developing severe disease, the number of available drugs is limited, and treatment is mainly symptomatic. *2 Therefore, there is an urgent need to find an easily accessible, safe and effective treatment for COVID-19.
What is Plasma Lactobacillus ?
In 2010 , Kirin discovered that Lactobacillus Plasma, a lactic acid bacterium, activates plasmacytoid dendritic cells (pDCs), the leaders of the immune system. Previous basic studies have shown that Plasma lactic acid bacteria stimulate pDCs to have first-line defense against viral infectious diseases. Previous clinical studies have also shown that Plasma lactic acid bacteria can stimulate pDC and inhibit the onset of disease caused by influenza virus, rotavirus and dengue fever. Based on these scientific evidences on immune function, Plasma lactic acid bacteria was registered as Japan's first*4 "Functional Indication Food" in August 2020.
Specific Clinical Research Content
Based on the results of research on Plasma lactic acid bacteria by Kirin Holdings, Nagasaki University, a research institution that has made important achievements in the field of infectious diseases , became interested in Plasma lactic acid bacteria , believing that it might alleviate the symptoms of patients with new coronary pneumonia, and decided to start from December 2021 Start specific clinical trials.
Since December 2021, Kirin Holdings has been participating in a program led by Dr. Kazuko Yamamoto, Instructor of Respiratory Medicine at Nagasaki University Hospital (currently Professor and Head of the Department of Infectious Diseases, Respiratory Medicine, and Gastroenterology (First Department of Internal Medicine) at the University of the Ryukyu Graduate School of Medicine) Specific clinical research projects. This is a multicenter, double-blind, randomized controlled trial conducted at Nagasaki University Hospital as the core facility. There are 50 patients with new coronary pneumonia in each group, and the efficacy and safety of 4 hard capsules containing Plasma lactic acid bacteria (a total of 400 billion Plasma lactic acid bacteria ) or 4 hard capsules without Plasma lactic acid bacteria (placebo) will be evaluated for 14 days *5.
2 New Coronary Pneumonia Drug Treatment Version 15.1 - Japan Infectious Diseases Association
3 The Secret of Immunity - Kirin's Plasma Lactobacillus Research
4 Japan's first food brand registered with the Consumer Agency claiming to have immune function.
5Yamamoto K et al. BMJ Open 2022;12:e061172
Designated Clinical Trial Results
1. Changes in the total score of subjective symptoms (primary endpoint)
Seven subjective symptoms (cough, shortness of breath, fatigue, headache, smell and taste disturbance, Anorexia and chest pain) analysis of global scores showed no difference between the two groups.
2. Disorders of smell and taste (secondary endpoint) (Figure 1)
After 9 days, a higher percentage of patients in the Plasma Lactobacillus group had a score of 0 (no effect) than in the placebo group for subjective symptoms of olfactory and taste dysfunction .
3. Change in blood pDC percentage (secondary endpoint) (Figure 2)
During the clinical course of COVID-19, the percentage of blood pDC in the placebo group decreased significantly, while that in the Plasma Lactobacillus group remained unchanged.
4. Percent Change in SARS-CoV-2 Viral Load (Secondary Endpoint) (Figure 3)
On day 4 of treatment, the viral load of SARS-CoV-2 was significantly reduced in the Plasma Lactobacillus group, while the decrease was seen in the placebo group on day 8.
5. Safety and Adverse Events
No serious safety adverse events were noted in this study.
Although the results of this study showed that the primary endpoint (Total Subjective Symptom Score) was unaffected, these results suggest that maintenance of pDC by ingestion of Lactobacillus Plasma may lead to faster reduction of SARS-CoV-2 viral load and earlier recovery Smell and taste functions.
Nagasaki University and Kirin hope that Plasma lactic acid bacteria will become one of the new treatments or adjuvant care methods for patients with mild symptoms of new coronary pneumonia.
About Kirin Holdings
Kirin Holdings Company, Limited is an international company operating in Japan and globally in the food and beverage field (food and beverage business), pharmaceutical field (pharmaceutical business) and health science field (health science business).
The origin of Kirin Holdings can be traced back to the Japanese brewery established in 1885. The Japanese brewery was renamed Kirin Brewery in 1907. Since then, the company has continuously expanded its business relying on core technologies such as fermentation and biotechnology, and entered the pharmaceutical business in the 1980s, all of which have successively become the core engines of the company's global growth. In 2007, Kirin Holdings was established as a pure holding company and is currently focusing on enhancing its health sciences segment.
According to the long-term management plan - Kirin Group Vision 2027 (KV 2027), launched in 2019, Kirin Group aims to become a "global leader in creating shared value, creating value in multiple business areas from food and beverage to pharmaceuticals " . Looking forward to the future, Kirin Group will continue to give full play to its own advantages, rely on business to create social and economic value, and achieve sustainable growth of corporate value.
* Create shared value: provide comprehensive added value for consumers and the whole society.
Plasma lactic acid bacteria (Photo: Business Wire)
Specific Clinical Research Content (Graphic: Business Wire)
Figure 1 (Graphic: Business Wire)
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Figure 3 (Graphic: Business Wire)