Clinical trial NCT04046432: Effects of Vigiis 101-LAB on a Healthy Populations' Gut Microflora, Peristalsis, Immunity, and Anti-oxidative Capacity
Official title: Effects of Vigiis 101-LAB on Gut Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Microbiome
Keywords: gut microflora
immunity
anti-oxidative capacity
Lactobacillus paracasei subsp. paracasei NTU 101
probiotics
Lead sponsor: SunWay Biotech Co., LTD.
Sponsor class: INDUSTRY
Collaborators: name: National Taiwan University Hospital
name: Chung Shan Medical University
First posted: 2019-08-06
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: a randomized, double-blind, placebo-controlled clinical study
Primary purpose: BASIC_SCIENCE

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged ≧ 20 years and ≦ 65 years.
* Subjects with normal weight (body mass index: 18.5-24).
* Subjects with no gastrointestinal diseases or on medication.

Exclusion Criteria:

* Pregnant or lactating women.
* Subjects who are allergic to Lactobacillus.
* Subjects with chronic gastrointestinal diseases.
* Subjects who previously underwent gastrectomy or gastric bypass.
* Subjects with liver, kidney, or heart disease, alcoholism, or uncontrolled diabetes.
* Subjects who developed stroke, psychiatric diseases, or depression within the last 1 year.
* Subjects being administered drugs that can regulate gastrointestinal function, functional foods, bacteriostatic drugs or supplements, antibiotics, antioxidants, or other unknown drugs within the last 2 weeks.
* Patients who did not fulfill the inclusion criteria, did not administer the test product according to regulations, whose efficacy could not be determined, or who had incomplete data that affect efficacy or safety assessment.

Primary outcomes:
measure: Gut Microflora
timeFrame: 4 week
measure: Peristalsis intestine
timeFrame: 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine
Study officials:
name: Tsong Ming Lu, MD
role: PRINCIPAL_INVESTIGATOR
name: Jyh Ming Liou, MD.,PHD
role: STUDY_DIRECTOR
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