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

NCT02176889 | Completed Phase 1

• 1 other identifier: 14PSHS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Lactospore; Bacillus coagulans; Safety; Probiotic; Healthy Adults; Tolerability

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Lactospore

EXPERIMENTAL

One tablet once daily, 30 minutes before a meal, preferably in the morning for 30 days

Dietary Supplement: Lactospore

Placebo

PLACEBO COMPARATOR

One tablet once daily, 30 minutes before a meal, preferably in the morning, for 30 days.

Other: Placebo

Interventions

Lactospore DIETARY_SUPPLEMENT

Bacillus coagulans MTCC 5856

Lactospore

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KGK Science Inc.: lead
• Sabinsa Corporation: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Study Officials

• Dale Wilson, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

CA (1)