Effects of Vigiis 101-LAB on a Healthy Populations' Gut Microflora, Peristalsis, Immunity, and Anti-oxidative Capacity
Condition: Gastrointestinal Microbiome
Study type: Interventional

Summary: 
      Vigiis 101-LAB capsules I and II are produced from the fermentation of Lactobacillus
      paracasei subsp. paracasei NTU 101. Investigators have examined the effects of the Vigiis
      101-LAB capsules I or II (5 or 10 billion CFU/day, respectively) on gut microflora in
      clinical trial 1, and on peristalsis, related immunity, and anti-oxidative capacity in
      clinical trial 2, during a 4-week randomized, double-blind, placebo-controlled,
      adaptive-design study.
    

Detailed description: 
      Detailed Description:

      1.1 Lactobacillus paracasei subsp. paracasei NTU 101 strain (NTU 101) is a local
      Lactobacillus strain that was isolated and selected from the guts of newborns in Taiwan and
      shows good adaptability, gastric acid resistance, and bile salt resistance characteristics.
      This strain can survive for long periods in the human gut, inhibit the growth of harmful
      bacteria, and play multiple roles. Studies have shown that the NTU 101 strain, or its
      fermented products, contribute to several functions, namely: (1) improving the function of
      gut microflora by preventing harmful bacteria from colonizing the gut, thereby exerting
      protective effects; (2) regulating the immune system by stimulating cell activation and
      proliferation and increasing the secretion of cytokines and antibodies to enhance innate and
      acquired immune responses; (3) repairing damage to the gastric mucosa by inhibiting acute
      gastric mucosal injury caused by pylorus ligation and acidified alcohol, decreasing lipid
      peroxide concentrations in the blood and gastric mucosa, increasing the activity of
      superoxide dismutase, and promoting the synthesis of prostaglandin E2, which protects the
      mucosa; and (4) the improvement of gastrointestinal functions that contribute to alleviating
      metabolic abnormalities by improving gastrointestinal function and metabolism. This study is
      divided into two sections and focuses on Lactobacillus supplementation effects on healthy
      people using NTU 101. Investigators conducted clinical trials to assess the effects of the
      Vigiis 101-LAB capsule I on improving gastrointestinal function and regulating gut flora
      (clinical trial 1), and the Vigiis 101-LAB capsule II on the improvement of peristalsis,
      immunity, and anti-oxidative capacity (clinical trial 2).

      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 I) containing 5 billion bacteria per capsule for
      the gut flora clinical trial 1. The Vigiis 101-LAB mixed lactose, crystalline cellulose, and
      excipient were also mixed into capsules (Vigiis 101-LAB capsule II) containing 10 billion
      bacteria per capsule for clinical trial 2 on peristalsis, immunity, and anti-oxidative
      capacity. 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 1) Vigiis 101-LAB capsule I 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 Randomized, double-blind clinical criteria for evaluating effects of Vigiis 101-LAB
      capsule II on peristalsis, immunity, and anti-oxidative capacity (clinical trial 2) Clinical
      trial 2 was conducted from March 2017 to April 2018 at the Chung Shan Medical University
      after acquiring approval from the IRB of the Taichung Chung Shan Medical University Hospital
      (IRB proof document CHMUH No: CS17018), and all subjects signed an informed consent form.
      Vigiis 101-LAB capsule II was administered orally once per day, one capsule each time. Every
      day, the diet of the subjects was recorded in detail from the pre-stability to post-stability
      period.

      1.5 Outcome measurements Fecal moisture content and pH value testing. Anthropometric
      measurements included the body height (BH), body weight (BW), blood pressure (BP), midarm
      circumference (MAC), triceps skinfold (TSF), waist circumference (WC), and rump circumference
      (RC) and heart rate (HR) were measured. The body mass index (= BW/BH2, kg/m2) of the subjects
      was calculated after measuring their BH and BW. For blood pressure measurements, the systolic
      blood pressure (SBP) and diastolic blood pressure (DBP) of the right arm were measured. MAC
      was measured using the same pair of calipers by the same trained staff member. Biochemical
      tests of the fasting blood samples were collected at weeks 0, 4, and 6. The test items
      included blood biochemistry tests, plasma antioxidant activity (Trolox equivalent antioxidant
      capacity, TEAC), thiobarbituric acid reactive substances (TBARS), glutathione levels (GSH),
      glutathione peroxidase (GSH Px), glutathione reductase (GSH Rd), full blood count, and blood
      electrolytes. Blood biochemical tests were carried out in the laboratory.

      1.6. 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 I or II (5 or 10 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; immunity; anti-oxidative capacity; Lactobacillus paracasei subsp. paracasei NTU 101; probiotics