Lactobacillus Plantarum P8 for Its Brain Health Promotion Potential (P8)

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Lactobacillus plantarum P8; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Penang
    • Universiti Sains Malaysia, Penang, Malaysia, 11900
      • School of Industrial Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female subjects
• 18-60 years old
• No severe illness
• BMI within a healthy range
• Score between 13 -20 (moderate stress level) on Cohen's Perceived Stress Scale (PSS)
• Willing to commit throughout the experiment

Exclusion Criteria:

• Type-1 diabetes (one of the main metabolite of Lactobacillus is acetic acid. Acetic acid has been reported to affect lipid metabolism in the liver and fat digestion in the pancreas in animal studies, and has been applied in obesity studies)
• Long term medication due to certain severe illness (certain medications may interfere with the survivability of Lactobacillus in the gut, for example the interactions between probiotics and warfarin
• HIV/AIDS (there has been no substantial data on the detrimental effects of probiotics on AIDS patients. However, AIDS patient may be immune-compromised in the sense of "leaky gut" that may lead to bacterial translocation, including translocation of Lactobacillus outside the gut environment, into the blood stream)
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (there has been no substantial data on the detrimental effects of probiotics on G6PD deficiency people. However, certain strains of probiotics have been reported to benefit RBC irregularity disorders such as spur cells formation. One of the main mechanisms, involve the alteration of RBC membrane. Although this is a benefit, we are unsure of the effects on G6PD deficiency people, with weaker RBC).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lactobacillus plantarum P8; Intervention consists of daily administration of 2g probiotic Lactobacillus plantarum P8, administered daily at a fixed dosage of 10 log CFU/sachet/day and continue for 12 weeks.	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.; Other Names: P8
Placebo Comparator: Placebo; Intervention consists of daily administration of 2g placebo (no probiotic bacteria), administered daily and continue for 12 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale (PSS) Scores	Stress Questionnaires for the determination of stress (low, moderate, high)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal microbiota profiling	Deoxyribonucleic acid (DNA) sequencing of fecal samples to compare DNA sequences of the different microbiota between adult participants taking P8 vs. placebo	12 weeks

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Collaborators: Beijing Scitop Bio-Tech Shareholding Co.Ltd.
• Investigators: Principal Investigator: Min Tze Liong, PhD, Universiti Sains Malaysia

Publications and helpful links

General Publications

• Kwok LY, Guo Z, Zhang J, Wang L, Qiao J, Hou Q, Zheng Y, Zhang H. The impact of oral consumption of Lactobacillus plantarum P-8 on faecal bacteria revealed by pyrosequencing. Benef Microbes. 2015;6(4):405-13. doi: 10.3920/BM2014.0063. Epub 2015 Feb 12.
• Wang L, Zhang J, Guo Z, Kwok L, Ma C, Zhang W, Lv Q, Huang W, Zhang H. Effect of oral consumption of probiotic Lactobacillus planatarum P-8 on fecal microbiota, SIgA, SCFAs, and TBAs of adults of different ages. Nutrition. 2014 Jul-Aug;30(7-8):776-83.e1. doi: 10.1016/j.nut.2013.11.018. Epub 2013 Dec 4.
• Lew LC, Hor YY, Yusoff NAA, Choi SB, Yusoff MSB, Roslan NS, Ahmad A, Mohammad JAM, Abdullah MFIL, Zakaria N, Wahid N, Sun Z, Kwok LY, Zhang H, Liong MT. Probiotic Lactobacillus plantarum P8 alleviated stress and anxiety while enhancing memory and cognition in stressed adults: A randomised, double-blind, placebo-controlled study. Clin Nutr. 2019 Oct;38(5):2053-2064. doi: 10.1016/j.clnu.2018.09.010. Epub 2018 Sep 19.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: USM/JEPeM/16050195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: General grouping data only

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No