Gastrointestinal Health, Respiratory Health, Safety
Conditions
Keywords
Probiotics, Gastrointestinal Health, Respiratory Health, Immunomodulation, Antioxidant, Chelation of heavy metals
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCocktail
Subjects will consume 2B CFU once daily containing .5B CFU DE111, .5B CFU MIT411, .5B CFU CGI314, and .5B CFU CSI08 for 45 days.
DIETARY_SUPPLEMENTCGI314
Subjects will consume 1B CFU of CGI314 once daily for 45 days.
DIETARY_SUPPLEMENTCSI08
Subjects will consume 1B CFU of CSI08 once daily for 45 days.
DIETARY_SUPPLEMENTMIT411
Subjects will consume 1B CFU of MIT411 once daily for 45 days.
Sponsors
Deerland Enzymes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 45 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunomodulation | 45 days | Evaluate difference in salivary IgA in experimental groups compared to placebo |
| Regularity | 45 days | 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. |
| GI Health | 45 days | Assess number of days with gastrointestinal problems in experimental groups compared to placebo. |
| Respiratory Health | 45 days | Assess number of days with respiratory infections in experimental groups compared to placebo. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Heart Health | 45 days | Assess the change in blood lipids from baseline to finish in experimental groups compared to plcaebo |
| Inflammation | 45 days | Assess the change in cytokines in experimental groups compared to placebo. |
Countries
Slovenia
Contacts
Primary ContactLilijana K Besednjak, MD PhD
Outcome results
None listed