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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Placebo; Dietary Supplement: Lactospore

• Registration Number: NCT02176889
• Lead Sponsor: KGK Science Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-08
• Last Update Posted: 2014-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	One tablet once daily, 30 minutes before a meal, preferably in the morning, for 30 days.
Lactospore	Lactospore	One tablet once daily, 30 minutes before a meal, preferably in the morning for 30 days

Primary Outcome Measures

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

Trial Locations

Locations (1)

KGK Synergize Inc.; 🇨🇦 London, Ontario, Canada