Stress Clinical Trial
Official title:
Lactobacillus Plantarum DR7 for Gut-Brain-Axis Benefits
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.
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 microbial balance, may affect the immune response, thus boosting the body system
to combat against diseases. While numerous microorganisms that may confer health benefits to
the host, the most widely studied probiotics are from the Lactobacillus genera. For the past
few decades, probiotics have been studied extensively for their beneficial effects mainly on
the host's guts. Recently, probiotics are studied for their promising potentials along the
gut-brain-axis. The 'gut-brain-axis' is a bidirectional communication system, dynamic for
maintaining homeostasis. Many studies show that certain strains of Lactobacillus improved
human's health such as reducing the occurrence of diarrhea caused by rotavirus infections,
antibiotic treatment, chemotherapy, or lactose intolerance, reduced irritable bowel syndrome
symptoms and treating atopic diseases. Lactobacillus have also gained increasing evidences as
an effective therapy in preventing respiratory tract infections such as sinusitis, bronchitis
and pneumonia. While the precise mechanisms of using Lactobacillus in management of
respiratory infections are largely unknown, speculations include: Lactobacillus compete
against pathogens; increase the barrier function in respiratory epithelium; immunostimulatory
effects by enhancing cellular immunity with increased activity of natural killer cells and
macrophages in airways. Lactobacilli, as one of the largest genera for probiotic
microorganisms have been researched to alleviate stress, anxiety and/or depression disorders.
Lactobacillus plantarum DR7 was isolated from fresh cow's milk in Penang, Malaysia. In-vitro
evaluation has shown that this putative probiotic strain adhere to the criteria of probiotic
characteristics; a) resistant towards acid and bile conditions of the upper gastrointestinal
tract, b) does not possess antibiotic resistance as per requirement of the European Food
Safety Authority (EFSA), c) able to adhere to mucin, d) has antioxidant properties, e) able
to utilize prebiotics such as fructooligosaccharide (FOS), inulin and galactooligosaccharide
(GOS), e) has a carbon metabolism profile adhering to the general patterns of lactobacilli,
and f) possess antimicrobial properties against gastrointestinal pathogens. In-vivo
evaluation using rats shown that this putative probiotic strain has gut protection
properties; a) modulation of gastrointestinal microbial profile via suppressing gut pathogen
populations and increasing the population of lactobacilli, b) decreasing pro-inflammatory
cytokines and increasing anti-inflammatory cytokines in the plasma, and c) reducing
inflammation in the lower intestines.
All these indicated that Lactobacillus plantarum DR7 has the potential to be an effective
probiotic strain that modulate gut health and immunity. In addition, due to the alleviation
of gastrointestinal stress, this strain may be beneficial along the gut-brain-axis to promote
brain health as well.
Lactobacillus plantarum DR7 and placebo are produced under GMP and HALAL certified
manufacturing facility. Probiotic Lactobacillus plantarum DR7 appears as light yellow powder.
Sachets are stored away from direct sunlight and in below 30C according to the storage
condition recommendations of the manufacturer. Each dose was supplied in an aluminium sachet
and all sachets are identical in taste and appearance. Probiotic Lactobacillus plantarum DR7
does not contain any porcine or bovine ingredients.
The product contains Lactobacillus plantarum DR7 and maltodextrin as excipient while placebo
contains only maltodextrin.
A total number of 124 healthy adults from age 18 -60 years old will be recruited for this
study.
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