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

NCT04046432 | Completed DMC

• 1 other identifier: sunway 001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Microbiome

Keywords

gut microflora; immunity; anti-oxidative capacity; Lactobacillus paracasei subsp. paracasei NTU 101; probiotics

Outcome Measures

Primary Outcomes (2)

• 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.

  4 week

• Peristalsis intestine

  Analysis of correlation between chyme passage time through the gut at 4 and 6 week in comparison with admission.

  6 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 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

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 I or II (5 or 10 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
• National Taiwan University Hospital: collaborator
• Chung Shan Medical University: collaborator

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

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Study Officials

• Tsong Ming Lu, MD

  PRINCIPAL INVESTIGATOR

• Jyh Ming Liou, MD.,PHD

  STUDY DIRECTOR

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: July 24, 2019
• First Posted: August 6, 2019
• Study Start: March 27, 2017
• Primary Completion: December 22, 2017
• Study Completion: March 20, 2018
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

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

Locations

TW (1)