Gastrointestinal Microbiome Clinical Trial
Official title:
Functional Assessment in The Intestinal Flora Improvement
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.
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).
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