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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Dietary supplement: Lactospore

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • KGK Synergize Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lactospore; One tablet once daily, 30 minutes before a meal, preferably in the morning for 30 days	Dietary supplement: Lactospore; Bacillus coagulans MTCC 5856
PLACEBO_COMPARATOR: Placebo; One tablet once daily, 30 minutes before a meal, preferably in the morning, for 30 days.	Other: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: KGK Science Inc.
• Collaborators: Sabinsa Corporation

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: June 25, 2014
• First Submitted That Met QC Criteria: June 26, 2014
• First Posted (ESTIMATE): June 27, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 9, 2014
• Last Update Submitted That Met QC Criteria: September 8, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Safety; Tolerability; Probiotic; Healthy Adults; Lactospore; Bacillus coagulans
• Other Study ID Numbers: 14PSHS