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

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ClinicalTrials.gov Identifier: NCT02176889
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : September 9, 2014
Sponsor:
Collaborator:
Sabinsa Corporation
Information provided by (Responsible Party):
KGK Science Inc.

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

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Lactospore Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Double-blind, Placebo-controlled, Parallel Study Evaluating the Safety of Lactospore® in Healthy Individuals
Study Start Date : June 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

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



Primary Outcome Measures :
  1. Safety and Tolerability: Lab parameters [ Time Frame: Over 30 days ]
    CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT, and bilirubin levels

  2. Safety and Tolerability: Anthropometric safety measures [ Time Frame: Over 30 days ]
    Blood pressure, Heart Rate, Weight, BMI

  3. Safety and Tolerability: Number of Adverse Events [ Time Frame: Over 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176889


Locations
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Canada, Ontario
KGK Synergize Inc.
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
KGK Science Inc.
Sabinsa Corporation
Investigators
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Principal Investigator: Dale Wilson, MD KGK Science Inc.

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Responsible Party: KGK Science Inc.
ClinicalTrials.gov Identifier: NCT02176889     History of Changes
Other Study ID Numbers: 14PSHS
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by KGK Science Inc.:
Lactospore
Bacillus coagulans
Safety
Probiotic
Healthy Adults
Tolerability