CTRI/2023/01/048913
Active, not recruiting
Phase 2
A prospective, interventional, randomized, double blind, parallel group, placebo controlled clinical study to evaluate the efficacy & safety of ProbioSEB CSC3™ (Bacillus coagulans LBSC plus Bacillus subtilis PLSSC plus Bacillus clausii 088AE) in immunomodulation in healthy adults - NA
Advanced Enzymes Technologies Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Advanced Enzymes Technologies Ltd
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Male/female healthy individuals aged 18\-65 years at the time of consent. 2\) Individuals who are literate and who are willing to give voluntary written informed consent.
Exclusion Criteria
- •1\) History of consumption of drugs or dietary or probiotic supplements related to immune function within two weeks prior to screening;
- •2\) Known case of hypersensitivity to the study product;
- •3\) Known case of hypertension, diabetes mellitus; any
- •history/presence of significant metabolic or autoimmune disease
- •4\) History/presence of acute or chronic disorders of cardiac, liver, kidney, or gastrointestinal system within last 6 months from screening;
- •5\) History/presence of any other acute or chronic disease requiring treatment condition, in the opinion of the investigator, which could jeopardize the study outcome;
- •6\) Females who are breast\-feeding/ pregnant, or intend to become
- •pregnant during the study.
Outcomes
Primary Outcomes
Not specified
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