Healthy Volunteers Clinical Trial
Official title:
Lactobacillus Plantarum P8 for Its Brain Health Promotion Potential
This project aims to study the benefits of probiotics namely Lactobacillus plantarum P8 for brain health properties, primarily alleviation of stress, among adults in Malaysia aged from 18 to 60 years.
The emerging concept of gut-brain-axis has been implying that gut health plays a pivotal role
in maintaining brain health4. Probiotics have entered the picture in promoting gut health for
better brain health. Probiotic can be defined as "live microorganisms that grant health
effects to the host if consumed in sufficient amounts". Lactobacilli, as one of the largest
genera for probiotic microorganisms have been researched to alleviate stress, anxiety and/or
depression disorders.
L. plantarum P8 was isolated from traditionally fermented sour milk samples collected from
herdsmen in Wulatezhongqi grassland, Bayannaoer, Inner Mongolia, China. L. plantarum P8 was
selected as it was the best among 347 other Lactobacillus strains with excellent tolerance to
gastric acid, intestinal fluid and bile salt of the digestive system. P8 is incorporated and
sold in the market of China, Taiwan and Singapore in a variety of products, ranging from
dairy (yoghurt and fermented milk), health supplements to pet foods. P8 is patented in China
and also awarded by the Chinese government as a functional probiotic. Two human clinical
trials have shown that the administration of P8 at a concentration of 10 log CFU/day for
4-weeks, improved gastrointestinal health of adults subjects via increasing the population of
beneficial gut microbiota accompanied by decreasing gut opportunistic pathogens, increasing
fecal levels of secretory immunoglobulin-A and short chain fatty acids.
Thus, with evidence from other studies supporting the stress-alleviation effects of
lactobacilli and the current gut modulation properties of P8, we believe that L. plantarum P8
could exert stress alleviation potentials as well.
P8 has confirmed its safety for consumption, and for this intervention, it will be produced
under ISO9001 and HALAL in China. HALAL certification is provided by ARA HALAL Development
Services Center Inc. (ARA), which is recognized by JAKIM, Malaysia, an organization that
oversees the implementation of Halal requirement in Malaysia.
A total number of 176 healthy adults from age 18 -60 years old will be recruited for this
study.
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