A Double-blind, Placebo-controlled, Parallel Study Evaluating the Safety of Lactospore® in Healthy Individuals

KGK Science Inc.1 site in 1 country40 target enrollmentJune 2014

ConditionsHealthy

Overview

The purpose of this study is to determine whether Lactospore is safe in healthy adults.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

August 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Male or female ≥18 years of age
•If female, subject is not of child bearing potential or female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
•Healthy as determined by laboratory results and medical history
•Normal BMI 18.5 - 29.9 kg/m2
•Has given voluntary, written, informed consent to participate in the study

•Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
•Subject has any clinically significant medical conditions
•Subject requires the use of prescribed medications (other than birth control)
•Use of illicit drugs or history of drug or alcohol abuse with the past 5 years (currently having more than 2 standard alcoholic drinks per day)
•Participation in a clinical research trial within 30 days prior to randomization
•Clinically significant abnormal laboratory results at screening
•Allergy or sensitivity to test product ingredients
•Individuals who are cognitively impaired and/or who are unable to give informed consent
•Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject