Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-24 @ 9:32 PM
NCT ID:
NCT04046432
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).
Study:
NCT04046432
Study Brief:
Protocol Section:
NCT04046432