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

Deerland Probiotics & Enzymes

Status: Unknown

Conditions: Respiratory Health; Gastrointestinal Health; Safety

Treatments: Dietary Supplement: Cocktail; Dietary Supplement: MIT411; Dietary Supplement: CGI314; Dietary Supplement: CSI08

Study type: Interventional

Funder types: Industry

Identifiers

NCT04758845

Pro5Safe

Details and patient eligibility

About

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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 5 patient groups

Cocktail

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Cocktail

CGI314

Experimental group

Description:

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

Treatment:

Dietary Supplement: CGI314

CSI08

Experimental group

Description:

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

Treatment:

Dietary Supplement: CSI08

MIT411

Experimental group

Description:

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

Treatment:

Dietary Supplement: MIT411

Placebo

No Intervention group

Description:

Subjects will consume 1 capsule containing maltodextrin for 45 days.