A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effect of Probiotics on Gut Function in Healthy Chinese Adults

Probi AB1 site in 1 country200 target enrollmentFebruary 8, 2023

Overview

The effect of probiotics on gut function in healthy subjects.

Registry

clinicaltrials.gov

Start Date

February 8, 2023

End Date

June 3, 2024

Last Updated

10 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Age between 18 and 65 years
•BMI between 18.5 and 27.9 kg/m²
•Subjects having ≥ 3 bowel movements per day
•Subject not satisfied with their bowel habits
•Subject having frequent stools during more than 4 weeks
•For women: Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study
•Subjects agreeing to keep their dietary and life habits unchanged throughout the study
•Good general and mental health within the opinion of the investigator
•Able and willing to participate to the study by complying with the protocol procedures as evidenced by a dated and signed ICF

•Suffering IBS according to Rome IV criteria, chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment
•Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator
•Suffering from a severe chronic disease or GI disorders found to be inconsistent with the conduct of the study by the investigator
•Intake of antibiotics within 8 weeks prior to the start of the study
•With regular intake of probiotics within four weeks prior to V1 visit
•Under treatment or dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the V1 visit
•Suspected alcohol or substance abuse
•Use of medications other than contraceptives or prescribed medication after consulting with the investigator
•History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk if participating in the study, or influence the results or the subject´s ability to participate in the study
•With a known gluten intolerance, milk protein allergy