On March 25th, the R&D Center of Jinqi Biological Group delivered another innovative result: the first domestic oral probiotic tablet IRB clinical trial was completed and published in the SCI journal.
This clinical trial is China's first independent research and development of three strains of bacteria (Lactobacillus salivarius AP-32, Lactobacillus paracasei ET-66, and Lactobacillus plantarum LPL28) with oral probiotic tablets by Penchi Biogroup. Form The first clinical RCT trial in China that passed the IRB review of oral probiotic lozenges, and achieved 4 new breakthroughs in the verification of the efficacy of oral probiotics in humans. The results were published in the "Oral Diseases" SCI journal (impact factor: 2.613). This means that new evidence of the effectiveness of live probiotics in the prevention of dental caries in China has ushered in new evidence that will benefit Chinese patients with oral diseases.
Four new breakthroughs
opens a new track for oral probiotic research
This clinical trial found that Lactobacillus salivarius AP-32 (Lactobacillus salivarius subsp. salicinius), Lactobacillus paracasei ET-66 (Lactobacillus paracasei), and Lactobacillus plantarum LPL28 (Lactobacillus plantarum) are very effective oral health food additives. Not only can it effectively reduce the number of Streptococcus mutans in the oral cavity, improve the microbial flora in the oral cavity, increase the performance of IgA antibodies in saliva, reduce oral infections, but also improve the intestinal symptoms of subjects, relieve constipation, reduce gastroesophageal reflux and Stomach pain, reduce the incidence of colds and daily drowsiness. Compared with deactivated bacteria and beneficial extracts, viable probiotics have more significant oral health functions and are the most excellent oral health food additives.
The results of this experiment have attracted much attention, mainly including the following four innovative breakthroughs:
1. The test method is scientifically verified: it has been formally approved by the hospital ethics committee, and the test method is scientifically feasible after review by medical, pharmacy, and legal experts.
2. High confidence interval: Use the RCT randomized double-blind controlled trial, the highest level of evidence-based medicine and the gold standard of clinical research, to conduct the trial, and the results of promoting oral health have higher credibility.
3. Breakthrough in testing technology: The first in China to verify the impact of probiotics on human oral microbes from the perspective of genetic sequencing, using a new generation of high-throughput sequencing NGS technology.
4. Breakthrough in oral probiotic formulations: The first domestic oral probiotic lozenge clinical trial, Jinqi Biological first applied three oral probiotics to oral probiotic lozenges for clinical effect verification.