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

NCT04088474 | Completed DMC

• 1 other identifier: Sunway002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Microbiome

Keywords

gut microflora; Lactobacillus paracasei subsp. paracasei NTU 101; probiotics

Outcome Measures

Primary Outcomes (1)

• Microflora analysis of fecal contents

  culture for intestinal defecation Bifidobacterium spp. Clostridium perfringens. Lactobacillus spp. and Escherichia coli

  4 week

Study Arms (2)

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. 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

placebo

PLACEBO COMPARATOR

Maltodextrin was used as a placebo.

Dietary Supplement: Placebo

Interventions

Vigiis 101-LAB DIETARY_SUPPLEMENT

examined the effects of the Vigiis 101-LAB capsules (5 billion CFU/day)

Vigiis 101-LAB

Placebo DIETARY_SUPPLEMENT

Maltodextrin was used as a placebo

placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SunWay Biotech Co., LTD.: lead

Study Sites (1)

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

Taipei, 104, Taiwan

Location

Related Publications (36)

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Study Officials

• Jyh Ming Liou, MD,PHD

  National Taiwan University Hospital

  STUDY DIRECTOR

• Tsong Ming Lu, MD

  Cheng Hsin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: a randomized, double-blind, placebo-controlled clinical study
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: a randomized, double-blind, placebo-controlled clinical study

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 12, 2019
• Study Start: March 5, 2016
• Primary Completion: July 6, 2016
• Study Completion: December 18, 2016
• Last Updated: September 13, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

TW (1)