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A large-scale clinical double-blind study conducted by the Faculty of Medicine of Chinese University of Hong Kong (CUHK) found that the microecological formula SIM01 developed by the Faculty of Medicine of University (CUHK) can reduce the common adverse reactions
of high-risk groups such as the elderly and diabetics after vaccination.
For the first time, the team found that the group taking SIM01 reduced the risk of bacterial and viral infections (including fever, dermatitis, septicaemia and new coronavirus pneumonia)
compared with the control group.
The research team further analyzed Shotgun metagenomic sequencing and confirmed that SIM01 can reshape a healthy intestinal microbiome and improve overall health
.
The results of this study show that SIM01 improves the intestinal microecology and enhances immunity against bacterial and viral invasion
.
SIM01 microbiome formula reshapes a healthy intestinal microbiome
An earlier study by the Faculty of Medicine of CUHK pointed out that unhealthy intestinal microbiomes are closely related to the severity of complications of novel coronavirus disease, and confirmed that the microecological formula SIM01 developed by CUHK can improve the symptoms of patients
.
The research team also tested blood samples from vaccinated people and found that the use of SIM01 could effectively reduce the inflammatory index after vaccination and increase the level
of antibodies against the virus.
To better understand the efficacy of SIM01 for at-risk individuals, CUHK Faculty of Medicine recruited a total of 453 chronically ill patients and individuals aged 65 or above to participate in the study
between 2021 and 2022.
Participants received the first dose of COVID-19 within one week before or after participating in the study, and were randomly assigned to take either a three-month microbiotic formula SIM01 or a placebo containing vitamin C (control group), with about half
of the participants.
Professor Lin Zhang, Assistant Professor of the Department of Medicine and Therapeutics, Faculty of Medicine, CUHK, said, "This study used a rigorous randomized, double-blind, placebo-controlled trial design and accurate metagenomic analysis to assess whether SIM01 can restore a healthy intestinal microbiome and enhance immunity against bacterial and viral infections
.
”
SIM01 can sustainably reduce adverse effects and improve health quality
It was found that participants taking the microbiome formula SIM01 had a lower
rate of adverse reactions (2.
9%) than the control group (12.
6%) one month after receiving the second dose of the new crown vaccine.
Regardless of the vaccine vaccine, participants taking SIM01 also had lower
rates of adverse reactions at the third month (0% vs.
3.
1%), sixth month (6.
2% vs.
16.
9%), and twelfth month (5.
4% vs.
17.
8%) than the control group 。 Compared with the control group, participants in the SIM01 group were also found to have better sleep quality (41.
4% vs.
19.
3%), more positive mood (21.
1% vs.
11.
4%) and improved skin quality (14.
1% vs 7.
0%)
.
SIM01 is formulated to reduce the risk of coronavirus and other infections
Another innovative finding of the team was that the group taking the microbiotic formula SIM01 had a significantly lower risk of developing the new coronavirus and other bacterial and viral infections (including dermatitis, septicaemia, and wound infection) than the control group (first month: 0.
5% vs.
5.
6%; Month 3: 0% vs.
0.
6%; Month 6: 4.
8% vs 15.
5%; Month 12: 5.
4% vs.
14.
4%), showing that SIM01 boosts immunity against other bacterial and viral infections
.
Professor Wong Chi-sang from the Jockey Club School of Public Health and Primary Care, Faculty of Medicine, CUHK, said, "Many elderly, children and chronically ill patients are still worried about the possible side effects
of the coronavirus vaccine.
In addition, in the pandemic, how to effectively improve the immunity of these high-risk groups to fight various infectious diseases is also the focus
of public concern.
This large-scale clinical double-blind study confirmed that SIM01 effectively reduces the risk of novel coronavirus and other bacterial and viral infections, including septicaemia
.
The results of the study are in line with the needs of society, especially the elderly and chronically ill patients
with weakened immunity.
”
Rebuilds a healthy gut microbiome to fight infections
Using metagenomics, the research team analyzed fecal samples from 283 citizens taking microbiome SIM01 or placebo for three months to assess changes in their intestinal microbiome
.
The results showed that after taking the SIM01 formula for three months, the number of many beneficial bacteria in the intestinal flora was significantly increased, and the content of various malignant bacteria was reduced at the same time, indicating that the SIM01 formula can reshape a healthy intestinal microbiome
.
Professor Wong Siew-kuen, Professor of the Department of Medicine and Therapeutics of the Faculty of Medicine and Director of the Hong Kong Microbiome Innovation Centre, explained that "A healthy gut microbiome can reduce the level of inflammatory cytokines in the body after vaccination, thereby reducing the risk of
adverse reactions.
Using precise metagenomics, we have demonstrated for the first time that SIM01 can improve the intestinal microbiome and boost immunity, which is especially important
for the elderly, diabetics and other chronically ill patients.
”
Professor Chan Ka-leung, Dean of the Faculty of Medicine and Director of the Gut Microbiota Research Centre, CUHK, concluded, "This large-scale clinical double-blind study is the first to combine clinical and laboratory precision bacterial gene analysis, further proving Hong Kong's strong medical research capabilities to translate scientific research results into products
that improve public health.
I hope that the Government will continue to invest resources and policy coordination to promote Hong Kong as a high-end international medical industry base
.
”
This research is supported
by the Health Research Fund of the Health Bureau.