HealthyPhase 114PSHSNCT02176889
A Parallel Study Evaluating the Safety of Lactospore® in Healthy Individuals
A Phase 1 study testing Lactospore in people with Healthy, run by KGK Science Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether Lactospore is safe in healthy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactospore
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Parallel Study Evaluating the Safety of Lactospore® in Healthy Individuals
The purpose of this study is to determine whether Lactospore is safe in healthy adults.
- Conditions
- Healthy
- Being tested
- Lactospore, Placebo
- Keywords
- Lactospore, Bacillus coagulans, Safety, Probiotic, Healthy Adults, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactosporeDietary supplement
Bacillus coagulans MTCC 5856
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Lactospore | Experimental | One tablet once daily, 30 minutes before a meal, preferably in the morning for 30 days Receives: Dietary Supplement: Lactospore |
| Placebo | Placebo comparator | One tablet once daily, 30 minutes before a meal, preferably in the morning, for 30 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability: Lab parameters
CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT, and bilirubin levels
Measured: Over 30 days
Safety and Tolerability: Anthropometric safety measures
Blood pressure, Heart Rate, Weight, BMI
Measured: Over 30 days
Safety and Tolerability: Number of Adverse Events
Measured: Over 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sabinsa Corporation
- Responsible party
- Sponsor
- Investigators
- Dale Wilson, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176889
- Sponsor's protocol ID
- 14PSHS
- Acronym
- 14PSHS
- Status last verified
- Sep 2014
- First submitted
- 25 Jun 2014
- Last updated
- 9 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Parallel Study Evaluating the Safety of Lactospore® in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02176889
- Acronym / sponsor ID
- 14PSHS / 14PSHS
- Conditions
- Healthy
- Keywords
- Lactospore, Bacillus coagulans, Safety, Probiotic, Healthy Adults, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sabinsa Corporation
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Lactospore is safe in healthy adults.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactospore | Experimental | Dietary Supplement: LactosporeOne tablet once daily, 30 minutes before a meal, preferably in the morning for 30 days |
| Placebo | Placebo comparator | Other: PlaceboOne tablet once daily, 30 minutes before a meal, preferably in the morning, for 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactosporeBacillus coagulans MTCC 5856 | Dietary supplement | Lactospore |
| Placebo | Other | Placebo |
Primary outcome
Safety and Tolerability: Lab parameters
Time frame: Over 30 days
CBC, electrolytes (Na, K, Cl), glucose, creatinine, AST, ALT, GGT, and bilirubin levels
Safety and Tolerability: Anthropometric safety measures
Time frame: Over 30 days
Blood pressure, Heart Rate, Weight, BMI
Safety and Tolerability: Number of Adverse Events
Time frame: Over 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dale Wilson, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactospore in people with Healthy, run by KGK Science Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability: Lab parameters (time frame: Over 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2014.