Gastrointestinal Microbiome Clinical Trial
Official title:
Effects of Vigiis 101-LAB on Gut Health
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:
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).
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