A Double-blind, Randomized Clinical Study, Compared With Placebo to Assess the Efficacy and Safety of a Probiotic Product Containing Four Probiotic Strains to Support Digestive Environment and Homeostasis of Gut Microbiota

Wecare Probiotics Co., Ltd.1 site in 1 country60 target enrollmentApril 25, 2024

ConditionsHealthy Adult

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy Adult
Sponsor: Wecare Probiotics Co., Ltd.
Enrollment: 60
Locations: 1
Primary Endpoint: Intestinal health
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the efficacy and safety of the probiotic product as an everyday gut health product in supporting digestive environment and homeostasis of gut microbiota.

Registry

clinicaltrials.gov

Start Date

April 25, 2024

End Date

June 25, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wecare Probiotics Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or Female subject age 18-60 years at screening
•Healthy subject according to investigator judgement based on screening data
•Subjects must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for the entire study
•Subjects who have not smoked in the past 1 month prior to screening
•Subjects with a healthy and balanced diet, including adequate fiber intake in their food consumption
•Subject or subject's legally acceptable representatives have the ability to comply with the trial protocol
•Signed informed consent from the subjects or subject's legally acceptable representatives (must be obtained before any trial related activities)

Exclusion Criteria

•History of presence of diabetes, immunodeficiency disorders, or chronic illness
•Regular use of medications known to affect the gastrointestinal system or alter gut microbiota composition, including but not limited to antibiotics, and immunosuppressants
•Have continuous, daily use of probiotic or probiotic containing products within 1 month prior to randomization
•Pregnant, planning a pregnancy or lactating female (urinary pregnancy test will be applied to female subjects at screening)
•Change type of diet during study
•Any known allergy or intolerance to any of the ingredients in the formulation of the product under study
•History of drug, alcohol or other substance abuse, or other factors that limit their ability to cooperate during the study
•History of or presence of eating disorder
•Subject whose condition does not make them eligible to the study, according to the investigator