Gastrointestinal MicrobiomeVigiis101NCT04046432
Effects of Vigiis 101-LAB on a Healthy Populations' Gut Microflora, Peristalsis, Immunity, and Anti-oxidative Capacity
A study testing Vigiis 101-LAB in people with Gastrointestinal Microbiome, run by SunWay Biotech Co., LTD. at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Microbiome
- What is being tested?
- Vigiis 101-LAB
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Mar 2017to 20 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine
Taipei, 104
About this study
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.
Read the 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).
- Conditions
- Gastrointestinal Microbiome
- Being tested
- Vigiis 101-LAB, Placebo
- Keywords
- gut microflora, immunity, anti-oxidative capacity, Lactobacillus paracasei subsp. paracasei NTU 101, probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigiis 101-LABDietary supplement
examined the effects of the Vigiis 101-LAB capsules I or II (5 or 10 billion CFU/day)
PlaceboDietary supplement
Maltodextrin was used as a placebo.
| Study group | Role | What they receive |
|---|---|---|
| Vigiis 101-LAB | Experimental | 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. Receives: Dietary Supplement: Vigiis 101-LAB |
| placebo | Placebo comparator | Maltodextrin was used as a placebo. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microflora
Outcome measurements:
Analysis of correlation between stool frequency and gut microbiota change of the gut microbiome will be calculated at 4 week in comparison with admission.
Measured: 4 week
Peristalsis intestine
Analysis of correlation between chyme passage time through the gut at 4 and 6 week in comparison with admission.
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start27 Mar 2017
- Primary completion22 Dec 2017
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- a randomized, double-blind, placebo-controlled clinical study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- SunWay Biotech Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital, Chung Shan Medical University
- Responsible party
- Sponsor
- Investigators
- Tsong Ming Lu, MD, Principal investigatorJyh Ming Liou, MD.,PHD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046432
- Sponsor's protocol ID
- sunway 001
- Acronym
- Vigiis101
- Status last verified
- Aug 2019
- First submitted
- 24 Jul 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Effects of Vigiis 101-LAB capsule I on improving gut microflora was examined Effects of Vigiis 101-LAB capsule II on improving gut peristalsis was examined Vigiis 101-LAB capsule I increased Bifidobacterium spp. and Lactobacillus spp. counts Vigiis 101-LAB capsule II improved gut motility and decreased food transiting time Vigiis 101-LAB capsule II increased IgG, IgM, and antioxidant activity
Publications
Agace WW, McCoy KD. Regionalized Development and Maintenance of the Intestinal Adaptive Immune Landscape. Immunity. 2017 Apr 18;46(4):532-548. doi: 10.1016/j.immuni.2017.04.004.
PubMed 28423335Arnao MB, Cano A, Hernandez-Ruiz J, Garcia-Canovas F, Acosta M. Inhibition by L-ascorbic acid and other antioxidants of the 2.2'-azino-bis(3-ethylbenzthiazoline-6-sulfonic acid) oxidation catalyzed by peroxidase: a new approach for determining total antioxidant status of foods. Anal Biochem. 1996 May 1;236(2):255-61. doi: 10.1006/abio.1996.0164.
PubMed 8660502Atarashi K, Tanoue T, Shima T, Imaoka A, Kuwahara T, Momose Y, Cheng G, Yamasaki S, Saito T, Ohba Y, Taniguchi T, Takeda K, Hori S, Ivanov II, Umesaki Y, Itoh K, Honda K. Induction of colonic regulatory T cells by indigenous Clostridium species. Science. 2011 Jan 21;331(6015):337-41. doi: 10.1126/science.1198469. Epub 2010 Dec 23.
PubMed 21205640Belkaid Y, Hand TW. Role of the microbiota in immunity and inflammation. Cell. 2014 Mar 27;157(1):121-41. doi: 10.1016/j.cell.2014.03.011.
PubMed 24679531Belkaid Y, Harrison OJ. Homeostatic Immunity and the Microbiota. Immunity. 2017 Apr 18;46(4):562-576. doi: 10.1016/j.immuni.2017.04.008.
PubMed 28423337Bengmark S. Gut microbiota, immune development and function. Pharmacol Res. 2013 Mar;69(1):87-113. doi: 10.1016/j.phrs.2012.09.002. Epub 2012 Sep 16.
PubMed 22989504Bridgman SL, Azad MB, Field CJ, Haqq AM, Becker AB, Mandhane PJ, Subbarao P, Turvey SE, Sears MR, Scott JA, Wishart DS, Kozyrskyj AL; CHILD Study Investigators. Fecal Short-Chain Fatty Acid Variations by Breastfeeding Status in Infants at 4 Months: Differences in Relative versus Absolute Concentrations. Front Nutr. 2017 Apr 10;4:11. doi: 10.3389/fnut.2017.00011. eCollection 2017.
PubMed 28443284Chen T, Isomaki P, Rimpilainen M, Toivanen P. Human cytokine responses induced by gram-positive cell walls of normal intestinal microbiota. Clin Exp Immunol. 1999 Nov;118(2):261-7. doi: 10.1046/j.1365-2249.1999.01047.x.
PubMed 10540188Chiang SS, Pan TM. Antiosteoporotic effects of Lactobacillus -fermented soy skim milk on bone mineral density and the microstructure of femoral bone in ovariectomized mice. J Agric Food Chem. 2011 Jul 27;59(14):7734-42. doi: 10.1021/jf2013716. Epub 2011 Jun 21.
PubMed 21668014Chiang SS, Liu CF, Ku TW, Mau JL, Lin HT, Pan TM. Use of murine models to detect the allergenicity of genetically modified Lactococcus lactis NZ9000/pNZPNK. J Agric Food Chem. 2011 Apr 27;59(8):3876-83. doi: 10.1021/jf104656m. Epub 2011 Mar 29.
PubMed 21410287Chiu CH, Lu TY, Tseng YY, Pan TM. The effects of Lactobacillus-fermented milk on lipid metabolism in hamsters fed on high-cholesterol diet. Appl Microbiol Biotechnol. 2006 Jun;71(2):238-45. doi: 10.1007/s00253-005-0145-0. Epub 2005 Sep 20.
PubMed 16172889Landi M. Commentary to: "Improving the thiobarbituric acid-reactive-substances assay for estimating lipid peroxidation in plant tissues containing anthocyanin and other interfering compounds" by Hodges et al., Planta (1999) 207:604-611. Planta. 2017 Jun;245(6):1067. doi: 10.1007/s00425-017-2699-3. Epub 2017 Apr 29. No abstract available.
PubMed 28456836Hooper LV, Littman DR, Macpherson AJ. Interactions between the microbiota and the immune system. Science. 2012 Jun 8;336(6086):1268-73. doi: 10.1126/science.1223490. Epub 2012 Jun 6.
PubMed 22674334Kao L, Liu TH, Tsai TY, Pan TM. Beneficial effects of the commercial lactic acid bacteria product, Vigiis 101, on gastric mucosa and intestinal bacterial flora in rats. J Microbiol Immunol Infect. 2020 Apr;53(2):266-273. doi: 10.1016/j.jmii.2018.06.002. Epub 2018 Jun 23.
PubMed 29970350Kamada N, Seo SU, Chen GY, Nunez G. Role of the gut microbiota in immunity and inflammatory disease. Nat Rev Immunol. 2013 May;13(5):321-35. doi: 10.1038/nri3430.
PubMed 23618829
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vigiis 101-LAB on Gut Health
- ClinicalTrials.gov ID
- NCT04046432
- Acronym / sponsor ID
- Vigiis101 / sunway 001
- Conditions
- Gastrointestinal Microbiome
- Keywords
- gut microflora, immunity, anti-oxidative capacity, Lactobacillus paracasei subsp. paracasei NTU 101, probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- SunWay Biotech Co., LTD.Industry (pharma, biotech, devices)
- Collaborators
- National Taiwan University Hospital, Chung Shan Medical University
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a randomized, double-blind, placebo-controlled clinical study
| Arm | Type | Receives |
|---|---|---|
| Vigiis 101-LAB | Experimental | Dietary Supplement: Vigiis 101-LABThe 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. |
| placebo | Placebo comparator | Dietary Supplement: PlaceboMaltodextrin was used as a placebo. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vigiis 101-LABexamined the effects of the Vigiis 101-LAB capsules I or II (5 or 10 billion CFU/day) | Dietary supplement | Vigiis 101-LAB |
| PlaceboMaltodextrin was used as a placebo. | Dietary supplement | placebo |
Primary outcome
Gut Microflora
Time frame: 4 week
Outcome measurements: Analysis of correlation between stool frequency and gut microbiota change of the gut microbiome will be calculated at 4 week in comparison with admission.
Peristalsis intestine
Time frame: 6 week
Analysis of correlation between chyme passage time through the gut at 4 and 6 week in comparison with admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Results publication: PubMed 28423335Agace WW, McCoy KD. Regionalized Development and Maintenance of the Intestinal Adaptive Immune Landscape. Immunity. 2017 Apr 18;46(4):532-548. doi: 10.1016/j.immuni.2017.04.004.
- Results publication: PubMed 8660502Arnao MB, Cano A, Hernandez-Ruiz J, Garcia-Canovas F, Acosta M. Inhibition by L-ascorbic acid and other antioxidants of the 2.2'-azino-bis(3-ethylbenzthiazoline-6-sulfonic acid) oxidation catalyzed by peroxidase: a new approach for determining total antioxidant status of foods. Anal Biochem. 1996 May 1;236(2):255-61. doi: 10.1006/abio.1996.0164.
- Results publication: PubMed 21205640Atarashi K, Tanoue T, Shima T, Imaoka A, Kuwahara T, Momose Y, Cheng G, Yamasaki S, Saito T, Ohba Y, Taniguchi T, Takeda K, Hori S, Ivanov II, Umesaki Y, Itoh K, Honda K. Induction of colonic regulatory T cells by indigenous Clostridium species. Science. 2011 Jan 21;331(6015):337-41. doi: 10.1126/science.1198469. Epub 2010 Dec 23.
- Results publication: PubMed 24679531Belkaid Y, Hand TW. Role of the microbiota in immunity and inflammation. Cell. 2014 Mar 27;157(1):121-41. doi: 10.1016/j.cell.2014.03.011.
- Results publication: PubMed 28423337Belkaid Y, Harrison OJ. Homeostatic Immunity and the Microbiota. Immunity. 2017 Apr 18;46(4):562-576. doi: 10.1016/j.immuni.2017.04.008.
- Results publication: PubMed 22989504Bengmark S. Gut microbiota, immune development and function. Pharmacol Res. 2013 Mar;69(1):87-113. doi: 10.1016/j.phrs.2012.09.002. Epub 2012 Sep 16.
- Results publication: PubMed 28443284Bridgman SL, Azad MB, Field CJ, Haqq AM, Becker AB, Mandhane PJ, Subbarao P, Turvey SE, Sears MR, Scott JA, Wishart DS, Kozyrskyj AL; CHILD Study Investigators. Fecal Short-Chain Fatty Acid Variations by Breastfeeding Status in Infants at 4 Months: Differences in Relative versus Absolute Concentrations. Front Nutr. 2017 Apr 10;4:11. doi: 10.3389/fnut.2017.00011. eCollection 2017.
- Results publication: PubMed 10540188Chen T, Isomaki P, Rimpilainen M, Toivanen P. Human cytokine responses induced by gram-positive cell walls of normal intestinal microbiota. Clin Exp Immunol. 1999 Nov;118(2):261-7. doi: 10.1046/j.1365-2249.1999.01047.x.
- Results publication: PubMed 21668014Chiang SS, Pan TM. Antiosteoporotic effects of Lactobacillus -fermented soy skim milk on bone mineral density and the microstructure of femoral bone in ovariectomized mice. J Agric Food Chem. 2011 Jul 27;59(14):7734-42. doi: 10.1021/jf2013716. Epub 2011 Jun 21.
- Results publication: PubMed 21410287Chiang SS, Liu CF, Ku TW, Mau JL, Lin HT, Pan TM. Use of murine models to detect the allergenicity of genetically modified Lactococcus lactis NZ9000/pNZPNK. J Agric Food Chem. 2011 Apr 27;59(8):3876-83. doi: 10.1021/jf104656m. Epub 2011 Mar 29.
- Results publication: PubMed 16172889Chiu CH, Lu TY, Tseng YY, Pan TM. The effects of Lactobacillus-fermented milk on lipid metabolism in hamsters fed on high-cholesterol diet. Appl Microbiol Biotechnol. 2006 Jun;71(2):238-45. doi: 10.1007/s00253-005-0145-0. Epub 2005 Sep 20.
- Results publication: PubMed 28456836Landi M. Commentary to: "Improving the thiobarbituric acid-reactive-substances assay for estimating lipid peroxidation in plant tissues containing anthocyanin and other interfering compounds" by Hodges et al., Planta (1999) 207:604-611. Planta. 2017 Jun;245(6):1067. doi: 10.1007/s00425-017-2699-3. Epub 2017 Apr 29. No abstract available.
- Individual participant dataSharing planned: Yes. Effects of Vigiis 101-LAB capsule I on improving gut microflora was examined Effects of Vigiis 101-LAB capsule II on improving gut peristalsis was examined Vigiis 101-LAB capsule I increased Bifidobacterium spp. and Lactobacillus spp. counts Vigiis 101-LAB capsule II improved gut motility and decreased food transiting time Vigiis 101-LAB capsule II increased IgG, IgM, and antioxidant activity
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Development and Validation of a Risk Prediction Model for Cardiac Surgery-associated Acute Kidney Injury Based on the Gut-Kidney Axis, Incorporating Gut Microbiota and Their Metabolites
Acute Kidney Injury After Adult Cardiac Surgery, Gastrointestinal Microbiome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsong Ming Lu, MD principal investigator
Jyh Ming Liou, MD.,PHD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vigiis 101-LAB in people with Gastrointestinal Microbiome, run by SunWay Biotech Co., LTD. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microflora (time frame: 4 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04046432, which also lists 49 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.