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

Study Overview
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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.

Official Title
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A Randomized, 5 Arm, Parallel, Placebo Controlled Clinical Study to Evaluate Safety and Efficacy of New Probiotic Strains in Healthy Adults

Conditions
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Gastrointestinal Health, Respiratory Health, Safety

Intervention / Treatment
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* Dietary Supplement: Cocktail
* Dietary Supplement: CGI314
* Dietary Supplement: CSI08
* Dietary Supplement: MIT411


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cocktail<br>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. | Dietary Supplement: Cocktail<br>* Subjects will consume 2B CFU once daily containing .5B CFU DE111, .5B CFU MIT411, .5B CFU CGI314, and .5B CFU CSI08 for 45 days.<br>|
| Experimental: CGI314<br>Subjects will consume 1 capsule containing 1B CFU of Bacillus coagulans CGI314 for 45 days. | Dietary Supplement: CGI314<br>* Subjects will consume 1B CFU of CGI314 once daily for 45 days.<br>|
| Experimental: CSI08<br>Subjects will consume 1 capsule containing 1B CFU of Bacillus clausiiCSI08 for 45 days. | Dietary Supplement: CSI08<br>* Subjects will consume 1B CFU of CSI08 once daily for 45 days.<br>|
| Experimental: MIT411<br>Subjects will consume 1 capsule containing 1B CFU of Bacillus megaterium MIT411 for 45 days. | Dietary Supplement: MIT411<br>* Subjects will consume 1B CFU of MIT411 once daily for 45 days.<br>|
| No Intervention: Placebo<br>Subjects will consume 1 capsule containing maltodextrin for 45 days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Participants will be asked to note any adverse events that might occur during 45 days study treatment period in the participant diary 1 and 14 days follow-up period in the participant diary 2 and to call the investigator if any clinically significant events occur. The investigator will review the returned participant diaries together with the participant. Based on the adverse events marked in the diaries and written in medical records the number of adverse event occurrences, their nature and causality will be evaluated in all study regimes. | 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunomodulation | Evaluate difference in salivary IgA in experimental groups compared to placebo | 45 days | 
| Regularity | Evaluate difference in stool consistency according to Bristol stool chart, and regularity of defecation from baseline to day 45 in experimental groups compared to control group and from baseline to end of 14 days follow up period (59 days) in the experimental groups compared to control group. Participants will be asked to track the type of their stool using the bristol stool chart, and times of defecation during the 45 day treatment period and 14 days follow up period in their diaries. On visit 2 and during the follow up phone call the investigator will review the participant diary together with the participant. | 45 days | 
| GI Health | Assess number of days with gastrointestinal problems in experimental groups compared to placebo. | 45 days | 
| Respiratory Health | Assess number of days with respiratory infections in experimental groups compared to placebo. | 45 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, Gastrointestinal Health, Respiratory Health, Immunomodulation, Antioxidant, Chelation of heavy metals