Clinical Study to Evaluate the Safety and Efficacy of New Probiotic Strains in Health Adults

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-11

Study Completion Date

2021-05-31

Brief Summary

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This trial is to determine the safety of 4 new probiotic strains and to assess their efficacy in reducing the incidence and/or duration of gastrointestinal problems and infections as well as respiratory infections in healthy adults.

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Detailed Description

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Conditions

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Gastrointestinal Health Respiratory Health Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cocktail

Subjects will consume 1 capsule containing 2B CFU containing .5B CFU Bacillus subtilis DE111, .5B CFU Bacillus coagulans CGI314, .5B CFU Bacillus megaterium MIT411, and .5B CFU Bacillus clausii CSI08 for 45 days.

Group Type EXPERIMENTAL

Cocktail

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume 2B CFU once daily containing .5B CFU DE111, .5B CFU MIT411, .5B CFU CGI314, and .5B CFU CSI08 for 45 days.

CGI314

Subjects will consume 1 capsule containing 1B CFU of Bacillus coagulans CGI314 for 45 days.

Group Type EXPERIMENTAL

CGI314

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume 1B CFU of CGI314 once daily for 45 days.

CSI08

Subjects will consume 1 capsule containing 1B CFU of Bacillus clausiiCSI08 for 45 days.

Group Type EXPERIMENTAL

CSI08

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume 1B CFU of CSI08 once daily for 45 days.

MIT411

Subjects will consume 1 capsule containing 1B CFU of Bacillus megaterium MIT411 for 45 days.

Group Type EXPERIMENTAL

MIT411

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume 1B CFU of MIT411 once daily for 45 days.

Placebo

Subjects will consume 1 capsule containing maltodextrin for 45 days.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cocktail

Subjects will consume 2B CFU once daily containing .5B CFU DE111, .5B CFU MIT411, .5B CFU CGI314, and .5B CFU CSI08 for 45 days.

Intervention Type DIETARY_SUPPLEMENT

CGI314

Subjects will consume 1B CFU of CGI314 once daily for 45 days.

Intervention Type DIETARY_SUPPLEMENT

CSI08

Subjects will consume 1B CFU of CSI08 once daily for 45 days.

Intervention Type DIETARY_SUPPLEMENT

MIT411

Subjects will consume 1B CFU of MIT411 once daily for 45 days.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent form. Healthy adults aged 18-65.

Exclusion Criteria

* Presence of a pre-existing adverse events monitored in the study. Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major GI surgery, chronic GI illness, abnormal intestinal anatomy or significant abdominal disorder. Severe chronic illness. Known immunodeficiency. Use of immunosuppressive agents. Presence of severe immunodeficient family members. Pregnancy, 6 months postpartum period or currently breastfeeding. Women of child bearing age planning pregnancy during the course of the study. Participation in another study. Not able to understand and comply with requirements of the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes