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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cocktail | Experimental | 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. |
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| CGI314 | Experimental | Subjects will consume 1 capsule containing 1B CFU of Bacillus coagulans CGI314 for 45 days. |
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| CSI08 | Experimental | Subjects will consume 1 capsule containing 1B CFU of Bacillus clausiiCSI08 for 45 days. |
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| MIT411 | Experimental | Subjects will consume 1 capsule containing 1B CFU of Bacillus megaterium MIT411 for 45 days. |
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| Placebo | No Intervention | Subjects will consume 1 capsule containing maltodextrin for 45 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cocktail | 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. |
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| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Health | Assess the change in blood lipids from baseline to finish in experimental groups compared to plcaebo | 45 days |
| Inflammation | Assess the change in cytokines in experimental groups compared to placebo. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lilijana K Besednjak, MD PhD | Contact | +38653383466 | lilijana.besednjak.kocijancic@zd-go.si |
| Name | Affiliation | Role |
|---|---|---|
| Lilijana K Besednjak, MD PhD | Health Center Nova Gorica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Center Nova Gorica | Recruiting | Sempeter pri Gorici | 5290 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37026366 | Derived | Rea K, Colom J, Simon EA, Khokhlova E, Mazhar S, Barrena M, Enrique M, Martorell P, Perez BA, Tortajada M, Phipps C, Deaton J. Evaluation of Bacillus clausii CSI08, Bacillus megaterium MIT411 and a Bacillus cocktail on gastrointestinal health: a randomised, double-blind, placebo-controlled pilot study. Benef Microbes. 2023 Apr 18;14(2):165-182. doi: 10.3920/BM2022.0117. Epub 2023 Apr 7. |
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| CGI314 | Dietary Supplement | Subjects will consume 1B CFU of CGI314 once daily for 45 days. |
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| CSI08 | Dietary Supplement | Subjects will consume 1B CFU of CSI08 once daily for 45 days. |
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| MIT411 | Dietary Supplement | Subjects will consume 1B CFU of MIT411 once daily for 45 days. |
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| 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 |
| 45 days |