Lactobacillus Plantarum DR7 for Gut-Brain-Axis Benefits
Condition: Stress
Study type: Interventional

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 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.
    

Intervention name(s): Lactobacillus plantarum DR7; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This project aims to study the benefits of probiotics namely Lactobacillus plantarum DR7 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years. Secondary emphases include respiratory and gastrointestinal health; This project aims to study the benefits of probiotics namely Lactobacillus plantarum DR7 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years. Secondary emphases include respiratory and gastrointestinal health
Other intervention name(s): DR7
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo and DR7 will be administered via a parallel design
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment