A Parallel Study Evaluating the Safety of Lactospore® in Healthy Individuals
NCT ID: NCT02176889
Last Updated: 2014-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2014-06-30
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Lactospore
One tablet once daily, 30 minutes before a meal, preferably in the morning for 30 days
Lactospore
Bacillus coagulans MTCC 5856
Placebo
One tablet once daily, 30 minutes before a meal, preferably in the morning, for 30 days.
Placebo
Interventions
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Lactospore
Bacillus coagulans MTCC 5856
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Sabinsa Corporation
INDUSTRY
KGK Science Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dale Wilson, MD
Role: PRINCIPAL_INVESTIGATOR
KGK Science Inc.
Locations
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KGK Synergize Inc.
London, Ontario, Canada
Countries
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Other Identifiers
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14PSHS
Identifier Type: -
Identifier Source: org_study_id
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