Status:
COMPLETED
Effects of Vigiis 101-LAB on a Healthy Populations' Gut Microflora, Peristalsis, Immunity, and Anti-oxidative Capacity
Lead Sponsor:
SunWay Biotech Co., LTD.
Collaborating Sponsors:
National Taiwan University Hospital
Chung Shan Medical University
Conditions:
Gastrointestinal Microbiome
Eligibility:
All Genders
20-65 years
Phase:
NA
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 ...
Detailed Description
Detailed Description: 1.1 Lactobacillus paracasei subsp. paracasei NTU 101 strain (NTU 101) is a local Lactobacillus strain that was isolated and selected from the guts of newborns in Taiwan and show...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2018
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04046432
Start Date
March 27 2017
End Date
March 20 2018
Last Update
August 7 2019
Active Locations (1)
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1
Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine
Taipei, Taiwan, 104