An interventional study of Cocktail and CGI314 in Gastrointestinal Health, Respiratory Health and Safety, sponsored by Deerland Enzymes. Status unknown at 1 site in Slovenia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-17.
Sponsored by Deerland Enzymes · Not applicable, Interventional, and Basic science
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.
Deerland Enzymes is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Subjects will consume 1 capsule containing 1B CFU of Bacillus coagulans CGI314 for 45 days.
Dietary Supplement: CGI314
Subjects will consume 1 capsule containing 1B CFU of Bacillus clausiiCSI08 for 45 days.
Dietary Supplement: CSI08
Subjects will consume 1 capsule containing 1B CFU of Bacillus megaterium MIT411 for 45 days.
Dietary Supplement: MIT411
Subjects will consume 1 capsule containing maltodextrin for 45 days.
Subjects will consume 2B CFU once daily containing .5B CFU DE111, .5B CFU MIT411, .5B CFU CGI314, and .5B CFU CSI08 for 45 days.
Subjects will consume 1B CFU of CGI314 once daily for 45 days.
Subjects will consume 1B CFU of CSI08 once daily for 45 days.
Subjects will consume 1B CFU of MIT411 once daily for 45 days.
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.
Time frame: 45 days
Immunomodulation
Evaluate difference in salivary IgA in experimental groups compared to placebo
Time frame: 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.
Time frame: 45 days
GI Health
Assess number of days with gastrointestinal problems in experimental groups compared to placebo.
Time frame: 45 days
Respiratory Health
Assess number of days with respiratory infections in experimental groups compared to placebo.
Time frame: 45 days
Heart Health
Assess the change in blood lipids from baseline to finish in experimental groups compared to plcaebo
Time frame: 45 days
Inflammation
Assess the change in cytokines in experimental groups compared to placebo.
Time frame: 45 days
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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