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

Healthy Clinical Trial

— 14PSHS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02176889
• Other study ID #: 14PSHS
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2014
• Last updated: September 8, 2014
• Start date: June 2014
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: KGK Synergize Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Lactospore
Bacillus coagulans MTCC 5856

Other:
• Placebo

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
KGK Synergize Inc.	Sabinsa Corporation

Country where clinical trial is conducted

Canada, 

Outcome

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