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

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Lactospore is safe in healthy adults.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Lactospore
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactospore<br>One tablet once daily, 30 minutes before a meal, preferably in the morning for 30 days | Dietary Supplement: Lactospore<br>* Bacillus coagulans MTCC 5856<br>|
| Placebo Comparator: Placebo<br>One tablet once daily, 30 minutes before a meal, preferably in the morning, for 30 days. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability: Lab parameters | CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT, and bilirubin levels | Over 30 days | 
| Safety and Tolerability: Anthropometric safety measures | Blood pressure, Heart Rate, Weight, BMI | Over 30 days | 
| Safety and Tolerability: Number of Adverse Events |  | Over 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactospore, Bacillus coagulans, Safety, Probiotic, Healthy Adults, Tolerability