A Parallel Study Evaluating the Safety of Lactospore® in Healthy Individuals (14PSHS)

KGK Science

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Other: Placebo

Dietary Supplement: Lactospore

Study type

Interventional

Funder types

Industry

Identifiers

14PSHS

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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