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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02176889

Acronym

14PSHS

Enrollment

Registered

2014-06-27

Start date

2014-06-30

Completion date

2014-08-31

Last updated

2014-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

Brief summary

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

Interventions

DIETARY_SUPPLEMENTLactospore

Bacillus coagulans MTCC 5856

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026