Effects of Lactobacillus Casei on Respiratory and Gastrointestinal Diseases in Adults
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang (LCZ)
      in prevention of upper respiratory and gastrointestinal illnesses, which are found common
      among adults in Malaysia aged from 18 to 81 years.
    

Detailed description: 
      Probiotic can be defined as "live microorganisms that grant health effects to the host if
      consumed in sufficient amounts". Probiotic bacteria, 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.

      Respiratory tract infections (RTI) can be described as infections on sinuses, throat, airways
      and lungs. Generally, RTI can be categorized into upper respiratory tract infections (URTI)
      and lower respiratory tract infections (LRTI). Some of the common URTI are like common cold,
      sinusitis, pharyngitis, epiglottitis and laryngotracheitis (croup) while examples of LRTI are
      bronchitis, bronchiolitis and pneumonia. URTI will be the main focus of this research.
      Despite continuous medical advancement, URTI remains a burden to the vast global
      communities.In Malaysia, URTI take out a proportion of 16.5% and 21.2% of the diseases
      diagnosed in public and private health clinics respectively.

      Diarrhea is one of the most common symptoms for gastrointestinal diseases. Diarrhea is
      commonly defined as three or more loose or watery stools in the last 24 hours. Probiotics
      such as Lactobacillus GG, Bifidobacterium lactis (alone or in combination with Streptococcus
      thermophiles), and Lactobacillus reuteri, Lactobacillus casei and Lactobacillus acidophilus
      have been reported to reduce diarrhea-related symptoms in a strain-dependent and
      dose-dependent manner. The rationale for using probiotics in infectious diarrhoea is that
      they act against enteric pathogens by competing for available nutrients and binding sites,
      making the gut contents acid, producing a variety of chemicals, and increasing specific and
      non-specific immune responses.

      Lactobacillus casei Zhang (LCZ) has been identified as a unique probiotic strain that shows
      favorable probiotic characteristics like high acid and bile tolerance, ability to colonize
      gastrointestinal tract, in addition to antibacterial, antioxidative and immunomodulatory
      properties. LCZ was first isolated from koumiss collected in Xilin Guole, Inner Mongolia,
      China by a group of researchers from Inner Mongolia Agricultural University. Koumiss is a
      type of fermented horse milk drink which is commonly found in Inner Mongolia, China and has
      been reported to treat digestive diseases and chronic diseases.

      LCZ is already commercially available and currently marketed in China since 2010, in the form
      of beverages, tablets, powders and capsules. Among the well known products present in the
      market are Bio-Plus, a type of plant based fermented soymilk beverages, Sci-Plus, and a
      multiple probiotic tablet. Research and development involving LCZ have won many awards. Among
      them are 2009 National Science and Technology Progress Award of China (second prize), 2009
      Inner Mongolia Natural Science Award (first prize) and the sixth DBN Technology Achievement
      Award. In addition, up to September 2014, 11 patents were filed and approved while 8 more
      patents were in the review stage. Besides that, 82 research papers related to LCZ were also
      published.

      Most research on LCZ have been related to improving human's health such as reduce
      susceptibility to type II diabetes and enhance human's immune system, and also related to
      food industry usage such as in cheese making industry. More importantly, many of probiotics
      have been reported to exert health benefits via maintain a healthy gut profile. In a recent
      clinical study, LCZ was found to significantly altered the composition of intestinal
      microbiota and the gut microbiota diversity, with a positive correlation with beneficial
      microorganisms such as Lactobacillus, Bifidobacterium and an unidentified genus from
      Bacteroidaceae, and a negative correlation with detrimental pathogens such as Clostridium,
      Serratia, Enterococcus, Shigella and Shewanella, with just a consumption of 28 days.

      LCZ has confirmed its safety for consumption, and for this intervention, it will be produced
      in a HACCP and ISO 22000 certified manufacturing plant (GeneFerm Biotechnology Co., Ltd.,
      Taiwan). LCZ does not contain any porcine or bovine ingredients and has obtained the Halal
      certification from Taiwan Halal Integrity Development Association (THIDA), Taiwan, which is
      recognized by Jabatan Kemajuan Islam Malaysia (JAKIM), an organization that oversees the
      implementation of Halal requirement in Malaysia.

      A total number of 150 healthy adults from age 18 -81 years old will be recruited for this
      study.
    

Intervention name(s): Lactobacillus casei Zhang; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang in prevention of upper respiratory and gastrointestinal illnesses, among adults in Malaysia aged from 18-81 years.; This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang in prevention of upper respiratory and gastrointestinal illnesses, among adults in Malaysia aged from 18-81 years.
Other intervention name(s): LCZ
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention