A Parallel Study Evaluating the Safety of Lactospore® in Healthy Individuals

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

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

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