Status:
COMPLETED
Lactobacillus Plantarum P8 for Its Brain Health Promotion Potential
Lead Sponsor:
Universiti Sains Malaysia
Collaborating Sponsors:
Beijing Scitop Bio-Tech Shareholding Co.Ltd.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03268447
Start Date
August 5 2017
End Date
January 31 2018
Last Update
July 3 2018
Active Locations (1)
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1
School of Industrial Technology
Universiti Sains Malaysia, Pulau Pinang, Malaysia, 11900