NCT03268447

Lactobacillus Plantarum P8 for Its Brain Health Promotion Potential

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Universiti Sains Malaysia · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus plantarum P8	This project aims to study the benefits of probiotics namely Lactobacillus plantarum P8 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years.
DIETARY_SUPPLEMENT	Placebo	This project aims to study the benefits of probiotics namely Lactobacillus plantarum P8 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years.

Timeline

• Start date: 2017-08-05
• Primary completion: 2018-01-31
• Completion: 2018-01-31
• First posted: 2017-08-31
• Last updated: 2018-07-03

Locations

1 site across 1 country: Malaysia