Status:
COMPLETED
Lactobacillus Plantarum DR7 for Gut-Brain-Axis Benefits
Lead Sponsor:
Universiti Sains Malaysia
Collaborating Sponsors:
Clinical Nutrition Sdn Bhd
Conditions:
Stress
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This project aims to study the benefits of probiotics namely Lactobacillus plantarum DR7 for brain health properties, primarily alleviation of stress, among adults in Malaysia aged from 18 to 60 years...
Detailed Description
Probiotics are "live microorganisms which, when administered in adequate amounts, can confer health benefits on the host". Probiotics, which beneficially affect the host by improving the intestinal mi...
Eligibility Criteria
Inclusion
- Male or female subjects
- 18-60 years old
- Willing to commit throughout the experiment
- Have moderate stress and beyond, as per determined by PSS test
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 :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2018
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03370458
Start Date
December 1 2017
End Date
March 31 2018
Last Update
July 3 2018
Active Locations (1)
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1
School of Industrial Technology, Universiti Sains Malaysia
Pulau Pinang, Pulau Pinang, Malaysia, 11800