Effects of Vigiis 101-LAB on a Healthy Populations' Gut Microflora
Condition: Gastrointestinal Microbiome
Study type: Interventional

Summary: 
      This clinical trial was conducted as part of the "Methods for Evaluating the Improvement of
      Gastrointestinal Function in Health Food" announced by the Department of Health, DOH
      (currently known as Ministry of Health and Welfare, MOHW) on the test article, "Vigiis
      101-LAB powder (Capsules)", manufactured by SunWay Biotech Co., Ltd.
    

Detailed description: 
      1.1 Introduction The human microbiome comprises diverse microbiologic ecosystems and is
      composed of a variety of bacteria, archaea, microeukaryotes, and viruses. Although
      investigators have appreciated the diversity of our microbial world for decades, scientists
      were constrained by the inability to culture many bacteria in the laboratory. Paradigms in
      biomedical science and medicine are changing in a fundamental way as investigators explore
      potential contributions of human-associated microbes to health and expand our understanding
      of disease susceptibility and pathogenesis. In the 21st century, investigators are attempting
      to develop a more balanced mindset as investigators seek to understand the role of the human
      microbiome in physiology and manipulate it to optimize health and prevent or treat disease.
      In recent years, investigators have increased our understanding of microbial communities and
      their corresponding metagenomes at different human body sites greatly. Healthy
      gastrointestinal (GI) microbiome should include age, sex, race/ethnicity, and diet. The Human
      Microbiome Project documented the importance of considering sex and race/ethnicity in
      evaluating differences between microbiomes of individuals. The human GI microbiome comprises
      diverse microbial communities that differ based on their location along the length of the GI
      tract (esophagus, stomach, small intestine, and large intestine or colon). Most human
      intestinal microbiome studies have relied on stool specimens. Probiotics have showed to
      possess anti mutagenic, anti carcinogenic and hypocholesterolemic properties. It is
      well-known that probiotics have a number of beneficial health effects in humans and animals,
      including the reduction of symptoms in lactose intolerance and enhancement of the bio
      availability of nutrients. Further, they were also observed to have antagonistic actions
      against intestinal and food-borne pathogens, to decrease the prevalence of allergies in
      susceptible individuals and to have immunomodulatory effects. Typically, the bacteria
      colonise the intestinal tract first and then reinforce the host defence systems by inducing a
      generalised mucosal immune response, balanced T-helper cell response, self-limited
      inflammatory response and secretion of polymeric IgA. Scientific reports showed that the
      Taiwan native lactic acid bacterium from newborn infant faeces identified as Lactobacillus
      paracasei subsp. paracasei NTU 101 and its fermented products proved to be effective for the
      management of blood cholesterol and pressure, prevention of gastric mucosal lesion
      development, immunomodulation and alleviation of allergies, anti-osteoporosis and inhibition
      the fat tissue accumulation.

      1.2 Materials The strain used in the current study was L. paracasei subsp. paracasei NTU 101
      (lyophilized powdered, Vigiis 101-LAB; probiotic powder from SunWay Biotech Co., Ltd.,
      Taipei, Taiwan). The Vigiis 101-LAB mixed lactose, crystalline cellulose, and excipient were
      made into capsules (Vigiis 101-LAB capsule) containing 5 billion bacteria per capsule for the
      gut flora clinical trial. Maltodextrin was used as a placebo.

      1.3 Randomized, double-blind clinical criteria of effects of Vigiis 101-LAB capsule I on gut
      flora (clinical trial) Vigiis 101-LAB capsule was administered orally once per day, one
      capsule each time. The entire study took 4 weeks, and subjects were prohibited from eating
      fermented food products, such as miso, kimchi, fermented dairy products,
      oligosaccharide-containing foods, and lactic acid bacteria-containing products. Subjects also
      avoided consuming excessive gas-producing foods (such as soybeans and sweet potatoes) during
      their daily meals and avoided foods that can cause abdominal distension or promote
      peristalsis (such as lactic acid beverages and oligosaccharide-containing beverages). After
      the trial started, subjects recorded their daily number of bowel movements and completed
      relevant questionnaires at weeks 0, 2, and 4. The subjects visited the doctor once every 2
      weeks for monitoring gastrointestinal function and physiological characteristics. At weeks 0,
      1, 2, 3, and 4, fecal samples from the subjects were collected and put into bottles
      containing an anaerobic diluent and shaken to uniformly mix the feces and diluent.

      1.4 Outcome measurements Fecal moisture content and pH value testing. Blood biochemical tests
      were carried out in the laboratory.

      1.5. Statistical analysis Data are expressed as the mean ± standard deviation (SD). The
      statistical significance of the biochemical analyses was determined by one-way analysis of
      variance (ANOVA) using the general linear model procedure of the statistical product and
      service solutions software (SPSS Institute, Inc., Chicago, IL, USA). This was followed by
      ANOVA with a paired t-test to evaluate the difference before and after sample and placebo
      administration, while the Student t-test was used to compare the difference between test and
      placebo groups (P ≤ 0.05).
    

Intervention name(s): Vigiis 101-LAB; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): examined the effects of the Vigiis 101-LAB capsules (5 billion CFU/day); Maltodextrin was used as a placebo
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: a randomized, double-blind, placebo-controlled clinical study
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: gut microflora; Lactobacillus paracasei subsp. paracasei NTU 101; probiotics