Effects of Vigiis 101-LAB on a Healthy Populations' Gut Microflora

September 11, 2019 updated by: SunWay Biotech Co., LTD.

Functional Assessment in The Intestinal Flora Improvement

This clinical trial was conducted as part of the "Methods for Evaluating the Improvement of Gastrointestinal Function in Health Food" announced by the Department of Health, DOH (currently known as Ministry of Health and Welfare, MOHW) on the test article, "Vigiis 101-LAB powder (Capsules)", manufactured by SunWay Biotech Co., Ltd.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

1.1 Introduction The human microbiome comprises diverse microbiologic ecosystems and is composed of a variety of bacteria, archaea, microeukaryotes, and viruses. Although investigators have appreciated the diversity of our microbial world for decades, scientists were constrained by the inability to culture many bacteria in the laboratory. Paradigms in biomedical science and medicine are changing in a fundamental way as investigators explore potential contributions of human-associated microbes to health and expand our understanding of disease susceptibility and pathogenesis. In the 21st century, investigators are attempting to develop a more balanced mindset as investigators seek to understand the role of the human microbiome in physiology and manipulate it to optimize health and prevent or treat disease. In recent years, investigators have increased our understanding of microbial communities and their corresponding metagenomes at different human body sites greatly. Healthy gastrointestinal (GI) microbiome should include age, sex, race/ethnicity, and diet. The Human Microbiome Project documented the importance of considering sex and race/ethnicity in evaluating differences between microbiomes of individuals. The human GI microbiome comprises diverse microbial communities that differ based on their location along the length of the GI tract (esophagus, stomach, small intestine, and large intestine or colon). Most human intestinal microbiome studies have relied on stool specimens. Probiotics have showed to possess anti mutagenic, anti carcinogenic and hypocholesterolemic properties. It is well-known that probiotics have a number of beneficial health effects in humans and animals, including the reduction of symptoms in lactose intolerance and enhancement of the bio availability of nutrients. Further, they were also observed to have antagonistic actions against intestinal and food-borne pathogens, to decrease the prevalence of allergies in susceptible individuals and to have immunomodulatory effects. Typically, the bacteria colonise the intestinal tract first and then reinforce the host defence systems by inducing a generalised mucosal immune response, balanced T-helper cell response, self-limited inflammatory response and secretion of polymeric IgA. Scientific reports showed that the Taiwan native lactic acid bacterium from newborn infant faeces identified as Lactobacillus paracasei subsp. paracasei NTU 101 and its fermented products proved to be effective for the management of blood cholesterol and pressure, prevention of gastric mucosal lesion development, immunomodulation and alleviation of allergies, anti-osteoporosis and inhibition the fat tissue accumulation.

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) containing 5 billion bacteria per capsule for the gut flora clinical trial. 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) Vigiis 101-LAB capsule 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 Outcome measurements Fecal moisture content and pH value testing. Blood biochemical tests were carried out in the laboratory.

1.5. 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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 104
        • Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Subjects who are allergic to Lactobacillus.
  3. Subjects with chronic gastrointestinal diseases.
  4. Subjects who previously underwent gastrectomy or gastric bypass.
  5. Subjects with liver, kidney, or heart disease, alcoholism, or uncontrolled diabetes.
  6. Subjects who developed stroke, psychiatric diseases, or depression within the last 1 year.
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Maltodextrin was used as a placebo.
Dietary supplement: Placebo
Maltodextrin was used as a placebo
Experimental: Vigiis 101-LAB
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. The Vigiis 101-LAB mixed lactose, crystalline cellulose, and excipient were also mixed into capsules (Vigiis 101- LAB capsule II) containing 5 billion bacteria per capsule for clinical trial.
Dietary supplement: Vigiis 101-LAB
examined the effects of the Vigiis 101-LAB capsules (5 billion CFU/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microflora analysis of fecal contents
Time Frame: 4 week
culture for intestinal defecation Bifidobacterium spp. Clostridium perfringens. Lactobacillus spp. and Escherichia coli
4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SunWay Biotech Co., LTD.

Investigators

  • Study Director: Jyh Ming Liou, MD,PHD, National Taiwan University Hospital
  • Principal Investigator: Tsong Ming Lu, MD, Cheng Hsin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2016

Primary Completion (Actual)

July 6, 2016

Study Completion (Actual)

December 18, 2016

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 12, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sunway002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Effects of Vigiis 101-LAB capsule on improving gut microflora was examined

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

Medicine / Nursing Medical Doctor Healthcare / Medical Management Medical Technician Pharmacist Nurse / Nursing Personnel Clinical Coodinator Clinical Researcher

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastrointestinal Microbiome

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe