Status:
UNKNOWN
Clinical Study to Evaluate the Safety and Efficacy of New Probiotic Strains in Health Adults
Lead Sponsor:
Deerland Enzymes
Conditions:
Gastrointestinal Health
Respiratory Health
Eligibility:
All Genders
18-65 years
Phase:
NA
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 respirato...
Eligibility Criteria
Inclusion
- Signed informed consent form. Healthy adults aged 18-65.
Exclusion
- 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.
Key Trial Info
Start Date :
February 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT04758845
Start Date
February 11 2021
End Date
May 1 2021
Last Update
February 17 2021
Active Locations (1)
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1
Health Center Nova Gorica
Šempeter pri Gorici, Slovenia, 5290