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Effects of Vigiis 101-LAB on a Healthy Populations' Gut Microflora, Peristalsis, Immunity, and Anti-oxidative Capacity (Vigiis101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04046432
Recruitment Status : Completed
First Posted : August 6, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
National Taiwan University Hospital
Chung Shan Medical University
Information provided by (Responsible Party):
SunWay Biotech Co., LTD.

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Microbiome Dietary Supplement: Vigiis 101-LAB Dietary Supplement: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: a randomized, double-blind, placebo-controlled clinical study
Masking: Single (Participant)
Masking Description: a randomized, double-blind, placebo-controlled clinical study
Primary Purpose: Basic Science
Official Title: Effects of Vigiis 101-LAB on Gut Health
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : March 20, 2018

Arm Intervention/treatment
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 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.
Dietary Supplement: Vigiis 101-LAB
examined the effects of the Vigiis 101-LAB capsules I or II (5 or 10 billion CFU/day)

Placebo Comparator: placebo
Maltodextrin was used as a placebo.
Dietary Supplement: Placebo
Maltodextrin was used as a placebo.




Primary Outcome Measures :
  1. 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.


  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046432


Locations
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Taiwan
Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine
Taipei, Taiwan, 104
Sponsors and Collaborators
SunWay Biotech Co., LTD.
National Taiwan University Hospital
Chung Shan Medical University
Investigators
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Principal Investigator: Tsong Ming Lu, MD
Study Director: Jyh Ming Liou, MD.,PHD

Publications of Results:

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Responsible Party: SunWay Biotech Co., LTD.
ClinicalTrials.gov Identifier: NCT04046432     History of Changes
Other Study ID Numbers: sunway 001
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: starting 6 months after publication.
Access Criteria:

醫療/護理 Medicine / Nursing

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


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SunWay Biotech Co., LTD.:
gut microflora
immunity
anti-oxidative capacity
Lactobacillus paracasei subsp. paracasei NTU 101
probiotics