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Trial record 55 of 227 for:    Intestinal | maltodextrin

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

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ClinicalTrials.gov Identifier: NCT04088474
Recruitment Status : Completed
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
SunWay Biotech Co., LTD.

Brief Summary:
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.

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 : 36 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: Functional Assessment in The Intestinal Flora Improvement
Actual Study Start Date : March 5, 2016
Actual Primary Completion Date : July 6, 2016
Actual Study Completion Date : December 18, 2016

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. 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)

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




Primary Outcome Measures :
  1. Microflora analysis of fecal contents [ Time Frame: 4 week ]
    culture for intestinal defecation Bifidobacterium spp. Clostridium perfringens. Lactobacillus spp. and Escherichia coli



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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:

  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.

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): NCT04088474


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

Publications of Results:

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Responsible Party: SunWay Biotech Co., LTD.
ClinicalTrials.gov Identifier: NCT04088474     History of Changes
Other Study ID Numbers: Sunway002
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Effects of Vigiis 101-LAB capsule on improving gut microflora was examined
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: starting 6 months after publication
Access Criteria: 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
Lactobacillus paracasei subsp. paracasei NTU 101
probiotics